Mechanical Ventilation ComplicationNCT06976554
Mechanical Ventilator Weaning in Chronically Ventilated Patients
A study testing weaning in people with Mechanical Ventilation Complication, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Mechanical ventilation is a commonly used life-saving hospital procedure for patients with severe breathing difficulty. Some patients have difficulty separating from the ventilator and need to be removed gradually. This process is called ventilator weaning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- weaning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 29 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring positive pressure mechanical ventilation for at least 21 days prior to BRH admission and
- Have a secure tracheostomy.
Who cannot join
- Inability to obtain informed consent from patient or DPOA
- Incarcerated patients
- Patients with less than 3 months of life expectancy
- Patients requiring vasopressor medication to stabilize blood pressure on admission
- Systolic blood pressure less than 90mmHg on admission
- Pulse less than 50 or greater than 130 beats per minute or change by more than 20 from baseline on admission
Show all 13Show fewer
- Respiratory rate greater than 35/min
- Oxygen saturation less than 90%
- PEEP>5cmH2O
- Lung tidal volume less than 250ml despite MV support
- At least one previous admission to BRH with unsuccessful ventilator liberation attempt
- Length of Stay (LOS) at BRH less than 24hours
- Patients pass spontaneous breathing trial (SBT) on D1 and eligible for cool aerosol, except if they fail SBT on D2 and require continued MV
Trial locations and contacts
1 site in 1 country.
United States1 site
Barlow Respiratory Hospital
Los Angeles, California, 90026
About this study
Mechanical ventilation is a commonly used life-saving hospital procedure for patients with severe breathing difficulty. Some patients have difficulty separating from the ventilator and need to be removed gradually. This process is called ventilator weaning. It is not known what is the best way to wean patients from the ventilator. In this study, the investigators will compare two commonly used ventilator weaning strategies and compare their success. One ventilator strategy, the Pressure Support Ventilation weaning (PSV), combines 12 hours ventilator weaning with 12 hours rest on the ventilator. This strategy is faster with an anticipated weaning in 2 weeks. The other strategy, the Therapist implemented Patient Specific weaning (TIPS), gradually lowers support and weans in 3 weeks.
Patients admitted to Barlow Respiratory Hospital (BRH) for ventilator weaning will be asked to participate in this study within 72 hours of hospital admission. Participants will undergo a spontaneous breathing trial (SBT) to assess your ability to breathe while receiving minimal or no ventilator support. Patients who pass SBT will be eligible for cool aerosol trials (humidified, oxygenated air without positive pressure mechanical ventilation). Participants who fail SBT within 24 hours will be eligible for the study. Participants will be randomized to receive PSV or TIPS ventilator weaning. The investigators will collect clinical, laboratory and mechanical ventilator information throughout the study period. Ventilator weaning success will be compared at day 30. The study will not interfere with any components of clinical care but the study investigators will be allowed to change the ventilator weaning strategy from PSV to TIPS, if a participant is unable to tolerate PSV weaning.
Read the detailed description
Study protocol:
- Patients will be considered for enrollment in the study within 72 hours of admission to BRH.
- All Barlow Respiratory Hospital (BRH) patients requiring positive pressure invasive mechanical ventilation (MV) undergo spontaneous breathing trial (SBT, pressure support ventilation (PS) 5cmH2O with 5cmH2O of positive end expiratory pressure, PEEP) per hospital policy within 24 hours of admission. Patients who pass SBT will be eligible for cool aerosol trials (humidified, oxygenated air without positive pressure mechanical ventilation). These patients will be excluded from the study, except if a patient fails to tolerate cool aerosol within 24 hours and continue require continuous positive pressure ventilation. These patients can be considered for study enrollment the next day.
- In the rare instance that a patient has an endotracheal tube on admission to BRH and continued MV is needed, a date for tracheostomy will be set. Patients following tracheostomy placement can participate in the study.
- Parameters to preclude study enrollment are listed in the Exclusion criteria.
- All patients are admitted to monitored beds at BRH. Vital signs (heart rate, oxygen saturation and lead 2 electrocardiogram, respiratory rate and ventilator compliance) are continuously monitored. Blood pressure is measured every 6 hours. Hemodynamic and respiratory stability is assessed daily on these parameters by the nurse and the respiratory therapist.
- On the first day of the study, Day0 (D0), if a patient is stable and required continued MV, the study team will approach the patient and/or the patient's designated power of attorney (DPOA) for informed consent.
- On D0, consented patients, now referred to as participants, will be randomized to participate in PSV or TIPS ventilator weaning.
- On Day 1 (D1), weaning starts. Hemodynamic and respiratory instability is assessed every day as in point 5. Unstable participants will complete the study, but will be followed throughout their hospitalization at BRH for hospital outcomes. Further weaning can be attempted after stabilization outside of the study protocol per the hospital weaning program.
- If a participant fails to progress to the next step of ventilator weaning, the same step can be repeated on 3 consecutive days and if possible can continue with the designated weaning path.
- If a participant cannot progress beyond the same step after 3 consecutive days in the PSV path, the participant will continue with TIPS path step 1.
- If a participant cannot progress beyond the same step after 3 consecutive days in the TIPS path, the participant will complete the study.
- Both paths will consist of a MV and a cool aerosol (CA) trial parts. The length of the TIPS path is a minimum 21 steps and 14 steps for the PSV path. These usually refer to days, but subjects may progress up to 3 steps in a day. The details of both path are shown in the "ventilator paths" section.
- When a participant is transitioned from MV to CA, arterial blood gas (ABG), will be collected after 2hrs CA to ensure adequate oxygenation and to avoid elevated carbon dioxide levels.
- Following completion of the study all participants will be assessed for tracheostomy decannulation by pulmonology, speech pathology and respiratory therapy.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- weaning
- Keywords
- prolonged mechanical ventilation, ventilator weaning, tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weaningProcedure or surgery
gradual weaning from the mechanical ventilator
| Study group | Role | What they receive |
|---|---|---|
| Therapist-implemented patient-specific (TIPS) ventilator weaning | Active comparator | In the TIPS path, participants will complete a 21 step protocol. Mechanical ventilator (MV) weaning is done with synchronized intermittent mandatory ventilation (SIMV) mode for 24 hrs. Patients will transition to this mode on the Day 1 (D1) after completion of SBT. The initial ventilator setup is PS 20 cmH2O PEEP 5cmH2O set RR 10/min. During the first 4 steps the backup rate will be lowered gradually from 8/min to 4/min (Step 1-4). Subsequently the PS will be reduced from 20 to 10 by each step (Step 5-9). SBT is performed in Step 10 with 1 hr. CA trials. ABG is performed in Step 11 with 2 hrs. of CA to assure respiratory stability. Patients rest on SIMV PS=10 cmH2O PEEP=5cmH2O, RR=4 (Step 9) setting during CA trial. Subjects can progress up to 3 steps daily, if deemed able by the respiratory therapist. The protocol completes when the patients is able to complete 72 hours of continuous CA time. Receives: Procedure: weaning |
| Pressure support ventilation (PSV) weaning | Active comparator | In the PSV path, participants will complete a 14-step protocol. In this protocol gradual decrease of PS is used for 10-12 hrs. a day. PS is decreased from 20cmH2O to 10cmH2O with 5cmH2O PEEP applied (Step 1-6). Every weaning step is followed by rest on the same ventilator setting the patient had on admission. Starting Step 7, subjects will undergo daily SBT (1 hour 5cmH2O PS with 5cmH2O PEEP). If they pass, they will progress to CA trials (Step 8-14). ABG is performed after 2 hours of CA time in Step 7 to assure respiratory stability. CA time will be extended by 4 hrs. in Step 8 to 14. Patients rest on the admission ventilator settings. Subjects can progress up to 3 steps daily, if deemed able by the respiratory therapist. The protocol completes when the patients is able to complete 72 hrs. of continuous CA time. Receives: Procedure: weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success
Patients who can disconnect from the mechanical ventilator for 3 consecutive days or have their tracheostomy decannulated will be considered weaned ("success") and will have completed the protocol.
Measured: 30 days
Secondary outcomes (5)
tracheostomy decannulation
Tracheostomy decannulation
Measured: 30 days
hospital length of stay
Hospital length of stay
Measured: throughout study completion, an average 90 days
intensive care unit admissions
Intensive care unit admissions at Barlow Respiratory Hospital
Measured: 30 days
in-hospital mortality
In-hospital mortality at Barlow Respiratory Hospital
Measured: throughout study completion, an average 90 days
physical activity score
Physical activity score on admission and at discharge
Measured: throughout study completion, an average 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Sep 2023
- Primary completion30 Jun 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized to intervention
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Barlow Respiratory Hospital
- Responsible party
- Principal investigator, Tamas Dolinay, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976554
- Sponsor's protocol ID
- 22-001420
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only deidentified data will be shared with the study team. This includes health demographics, comorbidities, blood laboratory values, vital signs, ventilator parameters, antibiotics, vasopressors use, health outcomes and discharge location.
Publications
Dolinay T, Jun D, Gogineni S, Hsu L, Maller A, Walsh BC, Gornbein J. Randomized clinical trial of ventilator liberation with pressure support ventilation versus therapist-implement patient-specific weaning in prolonged weaning patients via tracheostomy. BMC Pulm Med. 2026 May 8;26(1):291. doi: 10.1186/s12890-026-04341-9.
PubMed 42104281
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilator Weaning in Chronically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06976554
- Acronym / sponsor ID
- 22-001420
- Conditions
- Mechanical Ventilation Complication
- Keywords
- prolonged mechanical ventilation, ventilator weaning, tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Barlow Respiratory Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 16 May 2025 (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.
Mechanical ventilation is a commonly used life-saving hospital procedure for patients with severe breathing difficulty. Some patients have difficulty separating from the ventilator and need to be removed gradually. This process is called ventilator weaning. It is not known what is the best way to wean patients from the ventilator. In this study, the investigators will compare two commonly used ventilator weaning strategies and compare their success. One ventilator strategy, the Pressure Support Ventilation weaning (PSV), combines 12 hours ventilator weaning with 12 hours rest on the ventilator. This strategy is faster with an anticipated weaning in 2 weeks. The other strategy, the Therapist implemented Patient Specific weaning (TIPS), gradually lowers support and weans in 3 weeks.
Patients admitted to Barlow Respiratory Hospital (BRH) for ventilator weaning will be asked to participate in this study within 72 hours of hospital admission. Participants will undergo a spontaneous breathing trial (SBT) to assess your ability to breathe while receiving minimal or no ventilator support. Patients who pass SBT will be eligible for cool aerosol trials (humidified, oxygenated air without positive pressure mechanical ventilation). Participants who fail SBT within 24 hours will be eligible for the study. Participants will be randomized to receive PSV or TIPS ventilator weaning. The investigators will collect clinical, laboratory and mechanical ventilator information throughout the study period. Ventilator weaning success will be compared at day 30. The study will not interfere with any components of clinical care but the study investigators will be allowed to change the ventilator weaning strategy from PSV to TIPS, if a participant is unable to tolerate PSV weaning.
Detailed description
Study protocol:
- Patients will be considered for enrollment in the study within 72 hours of admission to BRH.
- All Barlow Respiratory Hospital (BRH) patients requiring positive pressure invasive mechanical ventilation (MV) undergo spontaneous breathing trial (SBT, pressure support ventilation (PS) 5cmH2O with 5cmH2O of positive end expiratory pressure, PEEP) per hospital policy within 24 hours of admission. Patients who pass SBT will be eligible for cool aerosol trials (humidified, oxygenated air without positive pressure mechanical ventilation). These patients will be excluded from the study, except if a patient fails to tolerate cool aerosol within 24 hours and continue require continuous positive pressure ventilation. These patients can be considered for study enrollment the next day.
- In the rare instance that a patient has an endotracheal tube on admission to BRH and continued MV is needed, a date for tracheostomy will be set. Patients following tracheostomy placement can participate in the study.
- Parameters to preclude study enrollment are listed in the Exclusion criteria.
- All patients are admitted to monitored beds at BRH. Vital signs (heart rate, oxygen saturation and lead 2 electrocardiogram, respiratory rate and ventilator compliance) are continuously monitored. Blood pressure is measured every 6 hours. Hemodynamic and respiratory stability is assessed daily on these parameters by the nurse and the respiratory therapist.
- On the first day of the study, Day0 (D0), if a patient is stable and required continued MV, the study team will approach the patient and/or the patient's designated power of attorney (DPOA) for informed consent.
- On D0, consented patients, now referred to as participants, will be randomized to participate in PSV or TIPS ventilator weaning.
- On Day 1 (D1), weaning starts. Hemodynamic and respiratory instability is assessed every day as in point 5. Unstable participants will complete the study, but will be followed throughout their hospitalization at BRH for hospital outcomes. Further weaning can be attempted after stabilization outside of the study protocol per the hospital weaning program.
- If a participant fails to progress to the next step of ventilator weaning, the same step can be repeated on 3 consecutive days and if possible can continue with the designated weaning path.
- If a participant cannot progress beyond the same step after 3 consecutive days in the PSV path, the participant will continue with TIPS path step 1.
- If a participant cannot progress beyond the same step after 3 consecutive days in the TIPS path, the participant will complete the study.
- Both paths will consist of a MV and a cool aerosol (CA) trial parts. The length of the TIPS path is a minimum 21 steps and 14 steps for the PSV path. These usually refer to days, but subjects may progress up to 3 steps in a day. The details of both path are shown in the "ventilator paths" section.
- When a participant is transitioned from MV to CA, arterial blood gas (ABG), will be collected after 2hrs CA to ensure adequate oxygenation and to avoid elevated carbon dioxide levels.
- Following completion of the study all participants will be assessed for tracheostomy decannulation by pulmonology, speech pathology and respiratory therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized to intervention
| Arm | Type | Receives |
|---|---|---|
| Therapist-implemented patient-specific (TIPS) ventilator weaning | Active comparator | Procedure: weaningIn the TIPS path, participants will complete a 21 step protocol. Mechanical ventilator (MV) weaning is done with synchronized intermittent mandatory ventilation (SIMV) mode for 24 hrs. Patients will transition to this mode on the Day 1 (D1) after completion of SBT. The initial ventilator setup is PS 20 cmH2O PEEP 5cmH2O set RR 10/min. During the first 4 steps the backup rate will be lowered gradually from 8/min to 4/min (Step 1-4). Subsequently the PS will be reduced from 20 to 10 by each step (Step 5-9). SBT is performed in Step 10 with 1 hr. CA trials. ABG is performed in Step 11 with 2 hrs. of CA to assure respiratory stability. Patients rest on SIMV PS=10 cmH2O PEEP=5cmH2O, RR=4 (Step 9) setting during CA trial. Subjects can progress up to 3 steps daily, if deemed able by the respiratory therapist. The protocol completes when the patients is able to complete 72 hours of continuous CA time. |
| Pressure support ventilation (PSV) weaning | Active comparator | Procedure: weaningIn the PSV path, participants will complete a 14-step protocol. In this protocol gradual decrease of PS is used for 10-12 hrs. a day. PS is decreased from 20cmH2O to 10cmH2O with 5cmH2O PEEP applied (Step 1-6). Every weaning step is followed by rest on the same ventilator setting the patient had on admission. Starting Step 7, subjects will undergo daily SBT (1 hour 5cmH2O PS with 5cmH2O PEEP). If they pass, they will progress to CA trials (Step 8-14). ABG is performed after 2 hours of CA time in Step 7 to assure respiratory stability. CA time will be extended by 4 hrs. in Step 8 to 14. Patients rest on the admission ventilator settings. Subjects can progress up to 3 steps daily, if deemed able by the respiratory therapist. The protocol completes when the patients is able to complete 72 hrs. of continuous CA time. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring positive pressure mechanical ventilation for at least 21 days prior to BRH admission and
- Have a secure tracheostomy.
Key exclusion criteria (13 listed)
- Inability to obtain informed consent from patient or DPOA
- Incarcerated patients
- Patients with less than 3 months of life expectancy
- Patients requiring vasopressor medication to stabilize blood pressure on admission
- Systolic blood pressure less than 90mmHg on admission
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 |
|---|---|---|
| weaninggradual weaning from the mechanical ventilator | Procedure or surgery | Pressure support ventilation (PSV) weaning, Therapist-implemented patient-specific (TIPS) ventilator weaning |
Primary outcome
weaning success
Time frame: 30 days
Patients who can disconnect from the mechanical ventilator for 3 consecutive days or have their tracheostomy decannulated will be considered weaned ("success") and will have completed the protocol.
5 secondary outcomes
tracheostomy decannulation
Time frame: 30 days
hospital length of stay
Time frame: throughout study completion, an average 90 days
intensive care unit admissions
Time frame: 30 days
in-hospital mortality
Time frame: throughout study completion, an average 90 days
physical activity score
Time frame: throughout study completion, an average 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 42104281Dolinay T, Jun D, Gogineni S, Hsu L, Maller A, Walsh BC, Gornbein J. Randomized clinical trial of ventilator liberation with pressure support ventilation versus therapist-implement patient-specific weaning in prolonged weaning patients via tracheostomy. BMC Pulm Med. 2026 May 8;26(1):291. doi: 10.1186/s12890-026-04341-9.
- Individual participant dataSharing planned: No. Only deidentified data will be shared with the study team. This includes health demographics, comorbidities, blood laboratory values, vital signs, ventilator parameters, antibiotics, vasopressors use, health outcomes and discharge location.
Related trials for Mechanical Ventilation Complication
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Not yet recruitingObservational study
Enteral Feeding in Mechanically Ventilated Children
Critical Illness, Mechanical Ventilation Complication
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weaning in people with Mechanical Ventilation Complication, run by University of California, Los Angeles at 1 site in United States.
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 13 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: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weaning success (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976554, which also lists 1 linked publication.
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 3 Aug 2025.