Hypoxic Respiratory FailureNCT06140056
Two Modes of Mechanical Ventilation for Intensive Care Patients With Low Blood Oxygen Due to Breathing Difficulties
A study testing Airway pressure release ventilation in people with Hypoxic Respiratory Failure and Ventilators, Mechanical, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
Trial summary
The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxic Respiratory Failure, Ventilators, Mechanical
- What is being tested?
- Airway pressure release ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 Dec 2023to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the ICU
- Invasive mechanical ventilation with FiO2 ≥ 50% OR PaO2-to-FiO2 ratio <20 kPa, including PEEP 3 5 cmH20 for at least 6 hours
Who cannot join
- Meeting inclusion criteria for more than 24 hours
- Severe bronchospasm, defined as warranting treatment aimed at reversing this i.e. inhalation of anticholinergic or bronchodilator beyond what the patient normally use
- Emphysema where treating physician judges the patient at increased risk for pneumothorax from APRV
- Restrictive lung disease defined as a pre-admission diagnosis of restrictive lung disease
- Undrained pneumothorax
- Hemodynamic instability defined as more than 0.20 microgram/kg/min of norepinephrine or any dose of adrenaline infusion to maintain MAP ≥ 65 mmHg
Show all 9Show fewer
- Age < 18 years
- Patients who have received APRV previously during the current ICU admission
- Patients in prone position within the last 24 hours
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg Hospital
Copenhagen, 2400
Hvidovre Hospital
Hvidovre, 2650
About this study
Official title: Transpulmonary Pressure During Volume Controlled Mechanical Ventilation Versus Airway Pressure Release Ventilation for Hypoxic Respiratory Failure - a Randomized Feasibility Study
The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.
Read the detailed description
As hypoxic respiratory failure is an acute condition, this trial will enrol temporarily incompetent patients and obtain consent from the patient's next of kin and an independent medical doctor (trial guardian) as soon as possible after enrolment.
When included in the study, patients will be randomized 1:1 centrally in the RedCap system, using a computer-generated concealed assignment sequence, with permuted blocks of varying sizes, to start with either the intervention (APRV) followed by control (volume controlled mechanical ventilation) or control followed by intervention.
Esophageal manometry will be used as a surrogate to measure the transpulmonary pressure. Arterial blood gasses, blood samples and lung ultrasound will be used to investigate oxygenation, ventilation and aeration.
Treatment targets for both groups during the study are pH >7.20, saturation ≥ 88% and PaO2 ≥ 8.0 kPa, with FiO2 titrated as low as possible while complying to the oxygenation targets (PaO2 and saturation).
Both arms start with an 'adjustment phase' where the ventilator is adjusted so the respiratory values are within the targets. The intervention adjustment phase is at least 30 minutes. The adjustments will follow standardized protocols.
When the respiratory values are within range, the 'observation period begins' and no changes are made to the ventilator for 3 hours, unless it is necessary to achieve ventilatory treatment targets or deemed necessary by the treating physician. During the trial, the patient must be positioned in a supine position with the headboard elevated 0-30 degrees.
After the first 'observation period', the patient is switched to the opposite ventilation mode and will go through an 'adjustment phase' and 'observation period' again.
Once a patient regains competence, they will be provided with both written and oral information regarding the trial
By comparing volume controlled mechanical ventilation and APRV and their transpulmonary pressures, valuable insight can be gained regarding optimal ventilation strategy for patients with hypoxic respiratory failure. Understanding how various ventilation modes influence transpulmonary pressure and their potential effects on respiratory mechanics can potentially inform designs of trials with individualized respiratory care.
- Being tested
- Airway pressure release ventilation, Volumen controlled mechanical ventilation
- Keywords
- Transpulmonary pressure, Airway pressure release ventilation, Volumen controlled mechanical ventilation, Esophageal pressure, Esophageal manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway pressure release ventilationOther
Mechanical ventilation mode
Volumen controlled mechanical ventilationOther
Mechanical ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Duration: 3 hours Receives: Other: Volumen controlled mechanical ventilation |
| Intervention | Experimental | Duration: 3 hours Receives: Other: Airway pressure release ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median peak transpulmonary pressure
Measured with esophageal manometry in cmH20.
Measured: During the observation period; 1-6 hours after randomization
Secondary outcomes (9)
Proportion of patients with peak transpulmonary pressure > 12 cmH2O
Measured with esophageal manometry
Measured: During observation period; 1-6 hours after randomization
Change in peak transpulmonary pressure in cmH20
Measured with esophageal manometry. Calculated as beginning - end of observation period
Measured: During observation period; 1-6 hours after randomization
Fluctuations in transpulmonary pressure in cmH20
Measured with esophageal manometry. Difference between peak and nadir transpulmonary pressure during respiratory cycle
Measured: During observation period; 1-6 hours after randomization
Change in fluctuations of transpulmonary pressure in cmH20
Measured with esophageal manometry. Calculated as beginning - end of observation period.
Measured: During observation period; 1-6 hours after randomization
Nadir PaO2-to-FiO2 ratio
Calculated by PaO2/FiO2. PaO2 from arterial blood gasses and FiO2 from ventilator setting
Measured: During observation period; 1-6 hours after randomization
Peak FiO2 in %
FiO2 from ventilator settings
Measured: During observation period; 1-6 hours after randomization
Peak PaCO2 in kPa
PaCO2 from arterial blood gasses
Measured: During observation period; 1-6 hours after randomization
Nadir pH
pH from arterial blood gasses
Measured: During observation period; 1-6 hours after randomization
Lung ultrasound aeration according to LUS
Evaluating lung aeration by Lung Ultrasound Score
Measured: During observation period; 1-6 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start8 Dec 2023
- Primary completion3 Aug 2025
- Study completion3 Sep 2025
Why it stopped: The study was terminated early due to slower than expected recruitment and limited resources for further enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theis S. Itenov, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Theis S Itenov, MD, PhD, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140056
- Sponsor's protocol ID
- H-23050947
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be owned by the steering committee. De-identified data will be made available 1 year after the primary publication of the outcome data. The statistical code will be submitted as an appendix to primary publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Pressure During Volume Controlled Mechanical Ventilation Versus Airway Pressure Release Ventilation for Hypoxic Respiratory Failure - a Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT06140056
- Acronym / sponsor ID
- H-23050947
- Keywords
- Transpulmonary pressure, Airway pressure release ventilation, Volumen controlled mechanical ventilation, Esophageal pressure, Esophageal manometry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to slower than expected recruitment and limited resources for further enrollment.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 3 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.
Detailed description
As hypoxic respiratory failure is an acute condition, this trial will enrol temporarily incompetent patients and obtain consent from the patient's next of kin and an independent medical doctor (trial guardian) as soon as possible after enrolment.
When included in the study, patients will be randomized 1:1 centrally in the RedCap system, using a computer-generated concealed assignment sequence, with permuted blocks of varying sizes, to start with either the intervention (APRV) followed by control (volume controlled mechanical ventilation) or control followed by intervention.
Esophageal manometry will be used as a surrogate to measure the transpulmonary pressure. Arterial blood gasses, blood samples and lung ultrasound will be used to investigate oxygenation, ventilation and aeration.
Treatment targets for both groups during the study are pH >7.20, saturation ≥ 88% and PaO2 ≥ 8.0 kPa, with FiO2 titrated as low as possible while complying to the oxygenation targets (PaO2 and saturation).
Both arms start with an 'adjustment phase' where the ventilator is adjusted so the respiratory values are within the targets. The intervention adjustment phase is at least 30 minutes. The adjustments will follow standardized protocols.
When the respiratory values are within range, the 'observation period begins' and no changes are made to the ventilator for 3 hours, unless it is necessary to achieve ventilatory treatment targets or deemed necessary by the treating physician. During the trial, the patient must be positioned in a supine position with the headboard elevated 0-30 degrees.
After the first 'observation period', the patient is switched to the opposite ventilation mode and will go through an 'adjustment phase' and 'observation period' again.
Once a patient regains competence, they will be provided with both written and oral information regarding the trial
By comparing volume controlled mechanical ventilation and APRV and their transpulmonary pressures, valuable insight can be gained regarding optimal ventilation strategy for patients with hypoxic respiratory failure. Understanding how various ventilation modes influence transpulmonary pressure and their potential effects on respiratory mechanics can potentially inform designs of trials with individualized respiratory care.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Volumen controlled mechanical ventilationDuration: 3 hours |
| Intervention | Experimental | Other: Airway pressure release ventilationDuration: 3 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the ICU
- Invasive mechanical ventilation with FiO2 ≥ 50% OR PaO2-to-FiO2 ratio <20 kPa, including PEEP 3 5 cmH20 for at least 6 hours
Key exclusion criteria (9 listed)
- Meeting inclusion criteria for more than 24 hours
- Severe bronchospasm, defined as warranting treatment aimed at reversing this i.e. inhalation of anticholinergic or bronchodilator beyond what the patient normally use
- Emphysema where treating physician judges the patient at increased risk for pneumothorax from APRV
- Restrictive lung disease defined as a pre-admission diagnosis of restrictive lung disease
- Undrained pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway pressure release ventilationMechanical ventilation mode | Other | Intervention |
| Volumen controlled mechanical ventilationMechanical ventilation mode | Other | Control |
Primary outcome
Median peak transpulmonary pressure
Time frame: During the observation period; 1-6 hours after randomization
Measured with esophageal manometry in cmH20.
9 secondary outcomes
Proportion of patients with peak transpulmonary pressure > 12 cmH2O
Time frame: During observation period; 1-6 hours after randomization
Change in peak transpulmonary pressure in cmH20
Time frame: During observation period; 1-6 hours after randomization
Fluctuations in transpulmonary pressure in cmH20
Time frame: During observation period; 1-6 hours after randomization
Change in fluctuations of transpulmonary pressure in cmH20
Time frame: During observation period; 1-6 hours after randomization
Nadir PaO2-to-FiO2 ratio
Time frame: During observation period; 1-6 hours after randomization
Peak FiO2 in %
Time frame: During observation period; 1-6 hours after randomization
Peak PaCO2 in kPa
Time frame: During observation period; 1-6 hours after randomization
Nadir pH
Time frame: During observation period; 1-6 hours after randomization
Lung ultrasound aeration according to LUS
Time frame: During observation period; 1-6 hours after randomization
Results and safety
The study was stopped early (reason given: The study was terminated early due to slower than expected recruitment and limited resources for further enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. All data will be owned by the steering committee. De-identified data will be made available 1 year after the primary publication of the outcome data. The statistical code will be submitted as an appendix to primary publication.
Related trials for Hypoxic Respiratory Failure
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingPhase 2
Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure
ARDS (Acute Respiratory Distress Syndrome), Acute Hypoxic Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theis S Itenov, MD, PhD principal investigator
University Hospital Bispebjerg and Frederiksberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway pressure release ventilation in people with Hypoxic Respiratory Failure and Ventilators, Mechanical, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to slower than expected recruitment and limited resources for further enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median peak transpulmonary pressure (time frame: During the observation period; 1-6 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.