Weaning Methods for Mechanical Ventilation Complications

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Vasopressors

Disqualifiers: Inability to consent, Incarceration, Life expectancy <3 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-3 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients at Barlow Respiratory Hospital who have been on mechanical ventilation and are struggling to wean off it. Within 72 hours of admission, those who pass a breathing test may try cool aerosol trials; those who fail can join the study. Participants must not have conditions that exclude them from the study.

Inclusion Criteria

I've been on a ventilator for 21 days and have a tracheostomy.

Exclusion Criteria

Lung tidal volume less than 250ml despite MV support

My breathing support settings are above a certain level.

Incarcerated patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants undergo ventilator weaning using either the PSV or TIPS strategy

2-3 weeks

Daily monitoring (in-person)

Follow-up

Participants are monitored for weaning success and hospital outcomes

4 weeks

Regular monitoring (in-person)

Long-term follow-up

Participants are assessed for tracheostomy decannulation and other outcomes

90 days

Treatment Details

Interventions

• Mechanical Ventilator Weaning

Trial Overview The study compares two ventilator weaning strategies: Pressure Support Ventilation (PSV), which aims for a faster wean in about 2 weeks, and Therapist implemented Patient Specific (TIPS) weaning, which takes around 3 weeks by gradually reducing support.

Participant Groups

Group I: Therapist-implemented patient-specific (TIPS) ventilator weaning Active Control 1 Intervention

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.

Group II: Pressure support ventilation (PSV) weaning Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Barlow Respiratory Hospital

Collaborator