Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

NCT07463885 | Not Yet Recruiting DMC

• 1 other identifier: UTN: U1111-1335-7858
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain. The SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure. The primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Acute Hypoxemic Respiratory Failure

Keywords

Acute respiratory distress syndrome; Acute hypoxemic respiratory failure; Mechanical ventilation; assisted ventilation; controlled ventilation; feasibility trial; randomised clinical trial

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  Proportion of eligible patients who are enrolled in the trial (primary feasibility outcome).

  1 year from trial initiation

Secondary Outcomes (20)

• Consent Rate

  1 year from trial initiation

• Randomisation Rate

  1 year from trial initiation

• Protocol Adherence

  1 year from trial initiation

• Major Protocol Violations

  1 year from trial initiation

• Retention Rate

  1 year from trial initiation

Study Arms (2)

Spontaneous ventilation

EXPERIMENTAL

Invasive mechanical ventilation in which the patient initiates some or all breaths, and the ventilator assists or supports those spontaneous efforts.

Procedure: Spontaneous Ventilation Strategy

Controlled ventilation

ACTIVE COMPARATOR

Invasive mechanical ventilation in which all breaths are delivered by the ventilator, with no patient-initiated respiratory effort.

Procedure: Controlled Ventilation Strategy

Interventions

Spontaneous Ventilation Strategy PROCEDURE

Invasive mechanical ventilation strategy allowing spontaneous breathing while receiving ventilatory support from a standard ICU mechanical ventilator.

Spontaneous ventilation

Controlled Ventilation Strategy PROCEDURE

Invasive mechanical ventilation strategy in which spontaneous respiratory effort is suppressed and breaths are fully delivered by a standard ICU mechanical ventilator.

Controlled ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include patients who fulfil all the following criteria:
• Acutely admitted to the ICU
• AND age ≥ 18 years
• AND invasive mechanical ventilation via endotracheal tube or tracheostomy for less than 24 hours
• AND moderate acute hypoxemic respiratory failure, defined as a PaO₂-FiO₂ ratio between 13.3-26.6 kPa (100-200 mmHg) with PEEP ≥ 5 cm H2O, based on arterial blood gas analysis obtained within 2 hours before randomisation.
• AND new pulmonary infiltrate (uni- or bilateral) on chest x-ray or CT-scan obtained no more than 24 hours before randomisation.

You may not qualify if:

• Previously randomised into the SVALBARD trial.
• Patient under coercive measures
• Withdrawal from active therapy or brain death deemed imminent.
• Chronic hypercapnic respiratory failure defined as PaCO2 \> 8 kPa (60 mm Hg) in the outpatient setting.
• Listed for lung transplant.
• Acute heart failure / acute myocardial infarction / cardiac arrest during or causing index ICU admission.
• Use of home oxygen.
• Chronic mechanical ventilation for any reason except for non-invasive mechanical ventilation (CPAP/BIPAP) used solely for sleep apnoea disorder.
• Currently receiving ECMO therapy.
• Burns \>70 % total body surface.
• Acute brain injury or stroke (any, including subarachnoid haemorrhage, SAH).
• Intracranial hypertension.
• Patients with planned repeat surgical interventions during current stay in ICU.

Sponsors & Collaborators

• Rigshospitalet, Denmark: collaborator
• Oslo University Hospital: lead
• Aalborg University Hospital: collaborator

Related Publications (5)

• Aslam TN, Klitgaard TL, Ahlstedt CAO, Andersen FH, Chew MS, Collet MO, Cronhjort M, Estrup S, Fossum OK, Frisvold SK, Gillmann HJ, Granholm A, Gundem TM, Hauss K, Hollenberg J, Huanca Condori ME, Hastbacka J, Johnstad BA, Keus E, Kjaer MN, Klepstad P, Krag M, Kvale R, Malbrain MLNG, Meyhoff CS, Morgan M, Moller A, Pfortmueller CA, Poulsen LM, Robertson AC, Schefold JC, Schjorring OL, Siegemund M, Sigurdsson MI, Sjovall F, Strand K, Stueber T, Szczeklik W, Wahlin RR, Wangberg HL, Wian KA, Wichmann S, Hofso K, Moller MH, Perner A, Rasmussen BS, Laake JH; SVALBARD investigators. A survey of preferences for respiratory support in the intensive care unit for patients with acute hypoxaemic respiratory failure. Acta Anaesthesiol Scand. 2023 Nov;67(10):1383-1394. doi: 10.1111/aas.14317. Epub 2023 Sep 22.

  PMID: 37737652 BACKGROUND

• Aslam TN, Klitgaard TL, Moller MH, Perner A, Hofso K, Skrubbeltrang C, Rasmussen BS, Laake JH. Spontaneous Versus Controlled Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome-A Scoping Review. Acta Anaesthesiol Scand. 2025 Sep;69(8):e70096. doi: 10.1111/aas.70096.

  PMID: 40757745 BACKGROUND

• Aslam TN, Klitgaard TL, Moller MH, Perner A, Hofso K, Skrubbeltrang C, Flaatten HI, Rasmussen BS, Laake JH. Spontaneous versus controlled mechanical ventilation in patients with acute respiratory distress syndrome - Protocol for a scoping review. Acta Anaesthesiol Scand. 2020 Jul;64(6):857-860. doi: 10.1111/aas.13570. Epub 2020 Mar 20.

  PMID: 32157683 BACKGROUND

• Laake JH, Smastuen MC, Moller MH, Larsson A, Aslam TN, Hofso K, Pham T, Fan E, Bellani G, Laffey JG; LUNG SAFE Investigators. Patient characteristics, management and outcomes in a Nordic subset of the "large observational study to understand the global impact of severe acute respiratory failure" (LUNG SAFE) study. Acta Anaesthesiol Scand. 2022 Jul;66(6):684-695. doi: 10.1111/aas.14069. Epub 2022 May 12.

  PMID: 35398892 BACKGROUND

• Aslam TN, Klitgaard TL, Hofso K, Rasmussen BS, Laake JH. Spontaneous Versus Controlled Mechanical Ventilation in Patients with Acute Respiratory Distress Syndrome. Curr Anesthesiol Rep. 2021;11(2):85-91. doi: 10.1007/s40140-021-00443-8. Epub 2021 Mar 3.

  PMID: 33679255 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Jon Henrik Laake, MD, PHD

CONTACT

0047 97660919; jlaake@ous-hf.no

Tayyba Naz Aslam, MD

CONTACT

tayasl@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: The SVALBARD feasibility study is designed as an international, multicentre, randomised, parallel-group pilot trial comparing two invasive mechanical ventilation strategies in adult intensive care unit (ICU) patients with moderately severe acute hypoxaemic respiratory failure. Eligible patients are randomised in a 1:1 ratio to either a spontaneous (assisted) ventilation strategy or a controlled ventilation strategy, with randomisation stratified by country of enrolment and biological sex, using concealed block randomisation.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03