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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help patients gradually stop using mechanical ventilators, which assist with breathing. It compares the Pressure Support Ventilation (PSV) method, which combines breathing assistance with rest periods over two weeks, to the Therapist-implemented Patient Specific (TIPS) method, which slowly reduces support over three weeks. The aim is to determine which approach more effectively helps patients breathe independently. This study may suit those who have been on a ventilator for at least 21 days and have a secure tracheostomy (a breathing tube placed in the neck). As an unphased trial, it offers a unique opportunity to contribute to important research that could improve ventilator weaning methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on ventilator weaning strategies, so it's best to discuss your medications with the study team.

What prior data suggests that these ventilator weaning methods are safe?

Previous studies have shown that the Therapist-implemented patient-specific (TIPS) weaning approach significantly reduces the time needed for patients to stop using mechanical ventilators. Research on the Pressure Support Ventilation (PSV) method links it to higher success rates in helping patients come off ventilators. Both methods are generally well-tolerated, meaning most patients can handle them without major problems.

Available studies report no severe adverse events for TIPS or PSV weaning strategies. However, both methods require close monitoring by healthcare providers to ensure patient safety.

Overall, current research findings suggest that both TIPS and PSV are safe options for helping patients stop using mechanical ventilators. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new methods for weaning patients off mechanical ventilators, aiming to improve outcomes and reduce complications. The trial compares two protocols: Therapist-implemented patient-specific (TIPS) weaning and Pressure support ventilation (PSV) weaning. TIPS is unique for its detailed 21-step process, which gradually adjusts ventilation settings to personalize the weaning journey. PSV, on the other hand, uses a streamlined 14-step protocol focused on reducing pressure support and conducting spontaneous breathing trials. By testing these approaches, the trial hopes to identify more effective and patient-friendly weaning strategies, potentially enhancing recovery times and overall patient health.

What evidence suggests that these ventilator weaning methods are effective for mechanical ventilation complications?

This trial will compare two weaning strategies for mechanical ventilation. Studies have shown that the Therapist-Implemented Patient-Specific (TIPS) weaning strategy, one method tested in this trial, effectively reduces the time patients spend on ventilators. It also increases the chances of successfully removing the breathing tube and shortens hospital stays. The Pressure Support Ventilation (PSV) method, another strategy under study, has also proven effective, with 79.1% of patients successfully breathing on their own during trials. Both strategies aim to gradually reduce ventilator support, but TIPS often uses a more personalized approach, linked to quicker weaning times. While both methods show promise, the choice may depend on individual patient needs and responses. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430712/

Ventilator Weaning - StatPearls - NCBI Bookshelf Prolonged mechanical ventilation increases the risk of pneumonia, barotrauma, tracheal injuries, and musculoskeletal deconditioning. At the same time, delayed ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209041

Spontaneous-Breathing Trials with Pressure-Support ... The initial spontaneous-breathing trial was successful in 383 patients (79.1%) in the PSV group and in 348 patients (71.7%) in the T-piece group (difference, ...

3. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-025-03744-4

Impact of pressure support ventilation duration after a ... A recent study demonstrated that reconnecting subjects to the ventilator for one hour after SBT resulted in lower reintubation rates among ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224002630

Weaning from mechanical ventilation in the operating room Based on low-quality evidence, PSV, individualised PEEP, and low FiO 2 may be associated with reduced postoperative pulmonary outcomes.

5. nature.com nature.com/articles/s41598-025-21370-2

Indicators of different outcomes after prolonged weaning 73.2% were successfully weaned, 36.1% without (3a) and 37.1% with subsequent non-invasive ventilation (3b). 20.2% were discharged with IMV (3cI) ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546706/

Pressure Support Ventilation - StatPearls - NCBI Bookshelf Pressure support ventilation (PSV) is a mode of positive pressure mechanical ventilation in which the patient triggers every breath.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2505708

Proportional-Assist Ventilation for Minimizing the Duration ... A pilot randomized trial comparing weaning from mechanical ventilation on pressure support versus proportional assist ventilation. Crit Care ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.731196/full

A Systematic Review and Network Meta-Analysis Firstly, we found that PSVs were associated with higher weaning success and SBT success, which is in agreement with previous results, but only these findings ...