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| Name | Class |
|---|---|
| Barlow Respiratory Hospital | UNKNOWN |
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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.
Study protocol:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| weaning | Procedure | gradual weaning from the mechanical ventilator |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| tracheostomy decannulation | Tracheostomy decannulation | 30 days |
| hospital length of stay | Hospital length of stay | throughout study completion, an average 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barlow Respiratory Hospital | Los Angeles | California | 90026 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42104281 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D014886 | Weaning |
| ID | Term |
|---|---|
| D007227 | Infant Nutritional Physiological Phenomena |
| D002664 | Child Nutritional Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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Randomized to intervention
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| intensive care unit admissions | Intensive care unit admissions at Barlow Respiratory Hospital | 30 days |
| in-hospital mortality | In-hospital mortality at Barlow Respiratory Hospital | throughout study completion, an average 90 days |
| physical activity score | Physical activity score on admission and at discharge | throughout study completion, an average 90 days |
| D010829 | Physiological Phenomena |