Recruiting

SBT with CPAP

Sponsor:

University Health Network, Toronto

Code:

NCT07017608

Conditions

Lung Transplant; Complications

Ventilator-Induced Lung Injury

Ventilator Associated Pneumonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Critically ill patients who (1) are not able to maintain their airway, (2) cannot breathe on their own, or (3) both, are ones who often require tracheal intubation and support from a breathing machine (mechanical ventilator). When the patient is ready to be liberated from the mechanical ventilator because the initial insult for intubation has been resolved, the patient is screened using the readiness to wean test in preparation for extubation. As the patient passes this screening, a spontaneous breathing test (SBT) is initiated. Currently, there are many debates surrounding which SBT technique is most favorable. At Toronto General Hospital, the clinical team uses a zero-end expiratory pressure (ZEEP) trial. Once the patient successfully passes their SBT they are then extubated.

The patient will undergo a spontaneous breathing trial of continuous positive airway pressure (CPAP) of 5 cmH2O and ZEEP, in which time the investigators will be using a new technology called electrical impedance tomography (EIT), to study and compare the end expiratory lung volume (EELV); investigators will use an esophageal catheter to measure and monitor pressures in the lung, and also assess the patient's work of breathing. This will be repeated once the patient has been extubated safely.

Conditions

Lung Transplant; Complications

Ventilator-Induced Lung Injury

Ventilator Associated Pneumonia

Study ID

NCT07017608

Start date

Sep 1, 2020

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients intubated and ventilated

Exclusion Criteria:

  • Contraindication for esophageal catheter insertion: upper gastrointestinal surgery within prior 6 weeks, actively bleeding esophageal varices
  • Bronchopleural fistula
  • Contraindication for electrical impedance tomography: chest burns, skin lesions in the thorax, chest wall bandaging limiting electrode placement, unstable spinal lesions or fractures
  • Pregnancy

Study Design

Enrollment

67 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in end-expiratory lung volume (EELV) between the varying conditions (CPAP 5, ZEEP, and post-extubation). [ Time Frame: Up to 30 minutes after extubation ]
  • Discriminative ability of occlusion maneuvers to detect expiratory muscle effort [ Time Frame: Up to 30 minutes after spontaneous breathing trial initiation ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 12, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-06-12.