Mechanical Ventilator Weaning in Chronically Ventilated Patients

NCT06976554 | Completed DMC

• 1 other identifier: 22-001420
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mechanical Ventilation Complication

Keywords

prolonged mechanical ventilation; ventilator weaning; tracheostomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• tracheostomy decannulation

  30 days

• hospital length of stay

  throughout study completion, an average 90 days

• intensive care unit admissions

  30 days

• in-hospital mortality

  throughout study completion, an average 90 days

• physical activity score

  throughout study completion, an average 90 days

Study Arms (2)

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.

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.

Procedure: weaning

Interventions

weaning PROCEDURE

gradual weaning from the mechanical ventilator

Pressure support ventilation (PSV) weaning; Therapist-implemented patient-specific (TIPS) ventilator weaning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring positive pressure mechanical ventilation for at least 21 days prior to BRH admission and
• Have a secure tracheostomy.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Barlow Respiratory Hospital: collaborator

Study Sites (1)

Barlow Respiratory Hospital

Los Angeles, California, 90026, United States

Location

MeSH Terms

Interventions

Weaning

Intervention Hierarchy (Ancestors)

Infant Nutritional Physiological Phenomena; Child Nutritional Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Randomized to intervention

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 16, 2025
• Study Start: September 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 29, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)