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Clinical Trials/CTRI/2023/05/053347
CTRI/2023/05/053347Not yet recruitingNot Applicable

Study to compare pressure support ventilation and T-piece as strategies of spontaneous breathing trials for weaning in ICU

Pt BD Sharma University of Health Sciences Rohtak Haryana1 site in 1 country80 target enrollmentStarted: May 15, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Comparison between success of T-piece trial and pressure support ventilation

Study Overview

Brief Summary

Spontaneous breathing trial is a method to identify readiness of extubation by incorporating a technique which allows gradual decrease in mechanical support of ventilator. SBT can be conducted by different methods like T-piece breathing, low level pressure support ventilation with or without PEEP, low level continuous airway pressure and flow trigger with no pressure applied to airway. There are some advanced methods of SBT like closed-loop systems with intelligent modes, adaptive support ventilation (ASV), neurally adjusted ventilatory assist (NAVA), and proportional assisted ventilation (PAV). Low level PSV and T piece are most common methods used for SBT. Low level PSV includes a pressure of upto 8 cm H2O in adults and upto 10 cm H2O in pediatric patients. In T-piece trial, patients are disconnected from ventilator and put on t-tube with oxygen support of 9-11 litres /min. SBT can be given for 30 to 120 minutes and after that success of trial can be monitored using subjective and objective criteria.

Depending on success of these SBTs, weaning can be classified further according to different classifications to assess success of weaning. We will be using WIND criteria. According to the success of SBT patients will be classified in following four weaning groups: 1. Group NW: patients who never experienced any separation attempt (SA); 2. Group 1: the first SA resulted in termination of the weaning process within 1 day 3. Group 2: weaning was completed after more than 1 day but in less than 1 week after the first SA 4. Group 3: weaning was not terminated by 7 days after the first SA Patients who will not be weaned off after 7 days will be regarded as failure of weaning.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Double Blind Double Dummy

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with age more than 18 years who are mechanically ventilated for minimum 24 hours but less than 7 days who are ready for spontaneous breahting trial.

Exclusion Criteria

  • Patients with
  • On vasopressor or inotropic support
  • Patients with underlying COPD, interstitial lung disease, damaged lung parenchyma due to any cause, single lung bronchopleural fistula or having intercostal drain in situ.
  • Patients whose weaning was terminated due to cause unrelated to weaning process.
  • Inability to obtain consent.

Outcomes

Primary Outcomes

Comparison between success of T-piece trial and pressure support ventilation

Time Frame: vitals recording and areterial blood gas analysis will be done at 20 minutes,40 minutes,and 60 minutes and second SBT will be given after 24 hours

for weaning according to WIND classification.

Time Frame: vitals recording and areterial blood gas analysis will be done at 20 minutes,40 minutes,and 60 minutes and second SBT will be given after 24 hours

Secondary Outcomes

  • To assess number of spontaneous breathing trials given for weaning in each group.(second SBT will be given after 24 hours and repeated untill success upto 1 week)

Investigators

Sponsor
Pt BD Sharma University of Health Sciences Rohtak Haryana
Sponsor Class
Government medical college

Study Sites (1)

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