Mechanical Ventilation and Extracorporeal Membrane Oxygenation in Acute Respiratory Insufficiency

Background: Invasive ventilation saves lives but carries major risks, including ventilation-associated lung damage and long-term functional impairment. Data from recent studies compel reassessment of the evidence for every step of the clinical treatment pathway.

Methods: This updated clinical practice guideline is based on pertinent publications retrieved by a systematic search in Medline, Embase, and the Cochrane Library up to April 2023, supplemented by further high-quality studies published up to June 2024. The recommendations were developed in evidence-to-decision–frameworks (EtDF) according to GRADE, with the participation of intensive-care nurses and early career clinician-scientists.

Results: For patients in acute respiratory failure, it is suggested that noninvasive respiratory support techniques should be used so that intubation can be avoided. It is further suggested that spontaneous breathing should be enabled early on during invasive ventilation. For the first time, the use of various techniques for titrating the positive end-expiratory pressure (PEEP) is suggested for patients with moderate to severe acute respiratory distress syndrome (ARDS). In such patients, techniques aiming at a higher PEEP can lower mortality by 9% in absolute terms (95% confidence interval [1; 16]) compared to lower-PEEP strategies. Strong recommendations are given against the routine use of muscle relaxation or corticosteroid therapy in moderate to severe ARDS. For patients with ARDS with a persistent, severe gas exchange disturbance after conservative options have been exhausted, veno-venous extracorporeal membrane oxygenation should be considered. VvECMO for patients with severe ARDS should be carried out at centers that are experienced in treating patients with severe ARDS and that fulfill specific structural requirements.

Conclusion: The goals of ventilator therapy should be to enable spontaneous breathing as soon as possible, keep respiratory parameters in the protective range, and adjust PEEP individually. Muscle relaxation or corticosteroids should not be part of the routine treatment of moderate to severe ARDS.

Cite this as: Fichtner F, Moerer O, Grundeis F, Bünger V, Laudi S, Sander M, on behalf of the Guideline Group on Mechanical Ventilation and Extracorporeal Membrane Oxygenation in Acute Respiratory Insufficiency: Clinical practice guideline: Mechanical ventilation and extracorporeal membrane oxygenation in acute respiratory insufficiency. Dtsch Arztebl Int 2026; 123: 169–74. DOI: 10.3238/arztebl.m2025.0225

Mechanical ventilation is an indispensable component of intensive care medicine for the treatment of acute respiratory insufficiency and many other critical conditions, but it is also an intervention associated with significant risks (1) and potential long-term sequelae (2). In Germany, just over 265 000 adults were mechanically ventilated in 2019 (3). Hospital mortality was 40.4% and rose markedly with age (18–59 years: 25.8% versus > 80 years: 55.8%). Total annual expenditure for ventilated adults was approximately 5.77 billion Euros (≈ 0.16–0.17% of gross domestic product [GDP]) (3).

Since the publication of the first version of the German clinical practice guideline “Mechanical ventilation and extracorporeal membrane oxygenation in acute respiratory insufficiency” (4), numerous randomized controlled trials and meta-analyses on key questions regarding ventilation therapy have been published. These questions include, among others:

• Noninvasive ventilation (NIV) and high-flow nasal oxygen (HFNO) compared with invasive ventilation (5)
• Early spontaneous breathing in severe acute respiratory distress syndrome (ARDS) (6)
• Individualized PEEP settings (7)
• The use of corticosteroids(8).

Furthermore, in light of the first positive study results, other international guidelines are also attaching increasing importance to structured communication with critically ill patients and their relatives (9).

At the same time, observational data from the COVID-19 pandemic in the German healthcare system—albeit not fully transferable to the non-pandemic care setting—point to considerable heterogeneity in treatment standards in clinical practice and to a high mortality rate among patients receiving extracorporeal membrane oxygenation (ECMO) compared to other countries (10, 11).

This made it necessary to carry out a comprehensive, evidence-based update of the guideline (12), once again aimed at providing a consensus-based and practice-oriented basis for information and decision-making for all professional groups working in intensive care units in German-speaking clinical care settings.

Methods

The clincial practice guideline project was coordinated and financed by the German Society of Anaesthesiology and Intensive Care Medicine (Gesellschaft für Anästhesiologie und Intensivmedizin, DGAI). The interprofessional guideline group (eTable) comprised 101 mandate holders (28 specialistsocieties/organizations).

eTable

Mandate holders and other participants

A systematic literature search (up to April 2023) was conducted in Medline, Embase, the Cochrane Library, and international guideline databases. Additional high-quality studies were included up until the recommendations were voted on in June 2024. In total, seven working groups identified 37 057 hits, reviewed 3970 full texts, and ultimately based the recommendations on 280 evaluated publications (eFigure). Evidence was assessed according to the internationally established GRADE system (13). The certainty (quality) of the evidence was classified into four categories, from high (++++) to very low (+), and an expert consensus (EC) was formulated if evidence was lacking.

eFigure

Example flow chart of the literature search and selection from Chap. 3.3 of the long version of the guideline on ventilation modes enabling spontaneous breathing (“Spontanatmung-ermöglichende Beatmungsverfahren”) (12)

The guideline group used, for the first time, the internationally established principle of the evidence-to-decision framework (EtDF) to develop the recommendations (14), in order to increase the clinical applicability and
acceptability of the recommendations by additionally taking into account, among other things, the values and preferences of those affected, the availability of resources, and practical feasibility.

To improve implementation, particular emphasis was placed on involving intensive care nurses throughout the entire development process. Also for the first time, young scientists systematically participated in the process, with early-career scientists working in intensive care actively involved in the entire guideline development process.

Results and recommendations

In the following, key new or modified recommendations of the German clinical practice guideline are presented as examples, together with details of the underlying evidence, and arranged according to the sequence of a typical clinical treatment pathway.

Noninvasive respiratory support options

For the initial treatment of mild to moderate hypoxemic respiratory failure, the guideline group—based on new aggregated study data—proposes the initial use of noninvasive respiratory support methods (NIV, continuous positive airway pressure [CPAP] or HFNO) (weak recommendation, quality of evidence: moderate). The 2023 network meta-analysis on which this is based (5) showed that NIV and HFNO significantly reduced the intubation rate compared with standard oxygen therapy (SOT) (absolute risk reduction [ARR]: NIV versus SOT: ARR 14% (95% confidence interval: [5; 20], HFNO versus SOT: ARR 6% [0.9; 11.3]). In contrast, however, no significant effect on mortality was observed. Risks could lie primarily in delayed intubation, that is, if ineffective NIV is continued for too long. Data from COVID-19 cohorts (15) indicate that this may be associated with an increased mortality rate.

Enabling early spontaneous breathing rather than routine neuromuscular blockade

The question of whether patients with early-stage ARDS should be ventilated in a controlled manner and placed under neuromuscular blockade, or whether spontaneous breathing should be allowed early on, has long been the subject of research. Here, the guideline group formulated a strong recommendation against the use of muscle relaxants in moderate to severe early-stage ARDS (< 48 h) (quality of evidence: moderate), and instead proposes the early use of respiratory support methods that enable spontaneous breathing (weak recommendation, quality of evidence: very low).

The recommendation is based on the ROSE trial (16)—the largest randomized controlled trial on this topic—which showed that the routine use of muscle relaxation in the first 48 h was not associated with either a survival benefit or a reduction in ventilation duration, but with an increased rate of serious cardiovascular events in the intervention group (intervention: 14/501 versus control: 4/505).

In contrast, the guideline group regards the indirect evidence from studies on the use of airway pressure release ventilation (APRV) and observational data from the LUNG SAFE trial (association between early spontaneous breathing and a reduction in ventilation days and a shorter intensive care unit stay) (6) as indicating a relevant patient benefit of early spontaneous breathing (< 48 h after intubation). A possible risk that has not yet been precisely quantified is patient self-inflicted lung injury (P-SILI) in cases of uncontrolled, forced spontaneous breathing (17). Based on the presented benefit–risk assessment and due to the very low quality of evidence, a weak recommendation is made here for the early use of assisted ventilation to enable spontaneous breathing in mechanically ventilated patients with acute respiratory insufficiency.

Advantages of methods supporting minute ventilation

The previous general classification of methods, in particular methods supporting spontaneous breathing, according to the respective interaction of spontaneous breathing and mechanical ventilation, remains unchanged:

• Ventilation methods that support tidal volume relieve each individual spontaneous inspiratory effort (e.g., pressure support ventilation [PSV]).
• Methods that support minute ventilation (MV) (for example, biphasic positive airway pressure [BIPAP] or APRV) enable spontaneous breathing, but ensure a minimal minute ventilation even in apnea through intermittent mechanical switching between pressure levels.
• Adaptive modes adjust the extent of mechanical support to the individual inspiratory efforts of the patient.

The strongest indications of a relevant patient benefit come from prospective studies on the minute ventilation-supporting mode APRV. In the original concept (18), spontaneous breathing was made possible during a long mechanical inspiratory phase—functionally during a “high CPAP”—after which the airway pressure was briefly reduced to ambient pressure before being increased again. Currently, due to the many different settings used for APRV in studies and the emergence of other MV-supporting modes (for example, BIPAP) in research and routine clinical practice, considerable heterogeneity has developed in the understanding of the nomenclature and characteristics of these methods (19). However, what all these methods have in common is the principle of pressure-controlled ventilation with the possibility of spontaneous breathing during the inspiratory and expiratory phases.

The evidence was assessed on the basis of meta-analyses of APRV (20, 21). This assessment was extrapolated to all MV-supporting methods involving pressure-controlled ventilation with the possibility of spontaneous breathing during the inspiratory and expiratory phases. The meta-analysis by Lim et al. (20) demonstrated a reduction in mortality among patients receiving APRV ventilation. With regard to the cumulative mortality in the control group, the absolute effect was approximately 10 fewer deaths per 100 patients (number needed to treat [NNT] ≈ 10; [6; 55]). As a further positive effect, the meta-analysis conducted by Carsetti et al. (21) demonstrated a reduction in cumulative intensive care unit length of stay of around 390 days per 100 patients. Subgroup analyses of ARDS patients showed consistent results, and no evidence of an increase in barotrauma compared to the control group was observed.

Taking into account the currently available evidence, the guideline group expanded the previous recommendation and, based on indirect evidence and a corresponding downgrade in the quality of evidence, now makes a weak recommendation in favor of the use of pressure-controlled ventilation with the option of spontaneous breathing during inspiration and expiration for the entire group of patients with acute hypoxemic respiratory failure (including ARDS) (quality of evidence: very low). At the same time, there is a possible risk of increased hyperinflation and greater work of breathing. This requires an individual benefit–risk assessment before and/or during use.

PEEP individualization and avoidance of prolonged recruitment maneuvers

Adjustment of positive end-expiratory pressure (PEEP) is a central element of mechanical ventilation. Here, both the type and severity of the gas exchange disturbance need to be taken into account. In mild ARDS, the ARDS Network FiO₂/low-PEEP table is recommended (22), while in moderate to severe ARDS, the use of higher PEEP levels continues to be recommended (strong recommendation, quality of evidence: high). What is new for the latter group, however, is the proposal of a selection of methods that can be used as alternatives to the FiO₂/PEEP table for individualizing PEEP, taking into account technical availability and operator expertise (Table) (weak recommendation, very low quality of evidence). Also new is the now strong recommendation against prolonged recruitment maneuvers (>60-s duration).

Table

Proposed methods for adjusting PEEP individually in patients with moderate and severe ARDS

The quality of evidence for the use of higher PEEP in moderate to severe ARDS is high. A network meta-analysis with over 4500 patients demonstrated that higher PEEP (7) in moderate to severe ARDS can reduce mortality (absolute reduction in mortality compared to a low-PEEP strategy: 9% ([1; 16]). Risks lie, in particular, in increased hemodynamic instability and the occurrence of barotrauma, explaining why individual titration remains an essential component. However, the low quality of evidence to date and the lack of indications pointing to the clear superiority of any single method with respect to patient-relevant outcome parameters ultimately permit only a weak general recommendation for methods of PEEP individualization (Table).

Corticosteroids: Avoiding overtreatment

For decades, the use of corticosteroids in ARDS has been the subject of controversy. The newly formulated recommendation is against the routine administration of corticosteroids in ARDS (quality of the evidence: very low). The background to this is the currently uncertain benefit–risk ratio of the treatment, which was thoroughly evaluated in the EtD framework, as well as the risk of overtreatment and potential harm perceived by the guideline group in the event of routine use.

Whereas the most recent large RCT of limited methodological quality (8) reported a reduction in the duration of mechanical ventilation, there are conflicting results from other RCTs on the question of whether corticosteroids reduce mortality (8, 23, 24, 25). At the same time, the risks of corticosteroid therapy have long been known, and current observational data—including those from the German healthcare system—suggest an association between corticosteroid treatment and increased mortality even in certain clinical courses of COVID-ARDS (26). The administration of corticosteroids can continue to be considered in mechanically ventilated patients with septic shock and persistent vasopressor requirements despite adequate fluid resuscitation (27).

Veno-venous extracorporeal membrane oxygenation: strict indication and adherence to structural requirements

For establishing the indication for veno-venous extracorporeal membrane oxygenation (vv-ECMO), a new and now evidence-based recommendation has been formulated: The use of vv-ECMO in patients with severe ARDS should only be considered after all conservative therapeutic measures, including prone positioning, have been exhausted and severe gas exchange disturbance persists (weak recommendation, quality of evidence: very low).

The EOLIA trial (28) failed to show a significant survival benefit for the routine use of vv-ECMO. At the same time, in the view of the guideline group, vv-ECMO therapy, as part of a comprehensive treatment concept, appears to reduce mortality in certain patients with severe ARDS. However, due to a lack of data, neither the exact subgroup nor the extent of the effect can be determined with greater precision at present.

To enable comprehensive treatment of ARDS and to minimize or optimally control its well-known serious complications (particularly bleeding, thrombosis, and vascular injury), the guideline group recommends that treatment be performed at centers experienced in the management of patients with severe ARDS, including vv-ECMO therapy, and has specified structural requirements to this end based on a systematic review of the literature (strong recommendations, expert consensus).

Weaning and WIND classification

For a more valid classification of the different clinical courses of weaning, the combined use of the WIND classification (29) and the subgroups of prolonged weaning as defined in the S2K guideline “Prolonged Weaning” (30) is recommended. Although the quality of evidence on this is low, initial investigations (31, 32) indicate that the WIND classification better reflects clinical outcomes in adults and children and represents clinical endpoints in a more nuanced manner than previously used classifications.

The need for patient and family information on long-term sequelae

In order to better deal with the long-term sequelae of mechanical ventilation, it is recommended that patients and their relatives be informed early on about the potential long-term effects (for example, on mental health) associated with mechanical ventilation (strong recommendation, expert consensus). The German DaCAPO study provides long-term data on survivors of ARDS (33). At 1 year post-discharge, a relevant proportion of patients still exhibited symptoms of posttraumatic stress disorder (32.6%), depression (8.9%), or an anxiety disorder (6.5%). At the same time, relevant gaps in the evidence regarding prevention, status assessment, and treatment of long-term sequelae of mechanical ventilation are evident.

The need for research to address gaps in the evidence

During the evidence analysis, several clinically relevant gaps were identified. These include, for example, the optimal balance between spontaneous breathing and mechanical ventilatory support in ARDS, the effectiveness of PEEP individualization methods in direct comparison, as well as the precise definition of ARDS patient subgroups who may still benefit from corticosteroids. Other relevant questions that remain open include the formulation and validation of more precise indication criteria for vv-ECMO treatment in severe ARDS, as well as the clinically valid assessment and quantification of long-term sequelae.

Conclusion

The updated clinical practice guideline is intended to provide an evidence-based foundation, agreed upon through interdisciplinary and interprofessional consensus, for mechanical ventilation therapy and the use of vv-ECMO. The recommendations regarding the following aspects are particularly relevant for current clinical practice:

• The use of NIV and HFNO to avoid intubation
• Strategies to enable early spontaneous breathing and individualized PEEP adjustment
• A restrictive approach to corticosteroids in ARDS
• Strictly individualized indications for vv-ECMO in severe ARDS
• Early provision of information to patients and families regarding possible long-term sequelae of mechanical ventilation.

The updated evidence-based treatment pathway is presented in the Box.

Box

Acute respiratory insufficiency: evidence-based treatment pathway*

Despite significant advances in knowledge as a result of new studies, important clinical questions—such as the selection and adjustment of ventilation parameters, the use of vv-ECMO therapy, and long-term sequelae—still need to be addressed scientifically in order to make the treatment and follow-up care of patients in acute respiratory failure in the intensive care unit even more patient-centered and, in an evidence-based manner, safer and more effective in the future.

Funding

The project to update the German S3 Clinical Practice Guideline on Mechanical Ventilation and the Use of Extracorporeal Procedures in Acute Respiratory Insufficiency during the 2022–2025 period was funded by the lead specialist society, the German Society of Anaesthesiology and Intensive Care Medicine (DGAI).

Conflict of interest statement

FF, FG, VB, and SL received reimbursement of travel expenses and congress fees from the DGAI.

OM received speaker’s fees from CSL Behring (coagulation) and Advitos GmbH (treatment of multi-organ failure). His department held Getinge-supported workshops (hemodynamic monitoring). Onnen Moerer received support (reimbursement of travel expenses and congress fees, as well as speaker honoraria) from the DIVI and the DGAI in the context of his participation in their respective annual congresses. He is spokesperson for the “Lung Failure” section of the DIVI.

MiS received speaker honoraria and consultancy fees from Edwards Life Sciences/BD. He received support (reimbursement of travel expenses and congress fees, as well as speaker honoraria) from the DIVI and the DGAI in the context of his participation in their respective annual congresses.

Manuscript submitted on 27 October 2025, revised version accepted on
25 November 2025.

Translated from the original German by Christine Rye.

Clinical practice guidelines in the Deutsches Ärzteblatt, as in many other journals, are not subject to a peer review process, since clinical practice (S3 level) guidelines are texts which have already been evaluated, discussed, and broadly agreed upon multiple times by experts (peers).

Corresponding author
Dr. med. Falk Fichtner

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