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Effectiveness of a simple breathing test to prevent the need for reinserting breathing tubes in ventilated children

Effectiveness of cuff leak test compared to standard care in reducing reintubation due to post-extubation airway obstruction in mechanically ventilated children: A pilot, single-centre, open-label, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107826
Enrollment
120
Registered
2026-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: J969- Respiratory failure, unspecified

Interventions

Intervention1: Cuff leak test result as a part of extubation readiness testing: Quantitative CLT will be performed and cuff leak percentage will be calculated as soon as patient is clinically deemed r
ETT cuff will be deflated, IV dexamethasone 0.5 mg/kg/dose (max 10 mg/dose) q6h upto 4 doses over 24 hours will be administered. CLT repeated after 24 hours
if pass, patient will be extubated. Extubation decision beyond second failed CLT at clinician discretion. Control Intervention1: Extubation readiness testing without using cuff leak test result: Child

Sponsors

AIIMS Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Mechanically ventilated via cuffed endotracheal tube for more than 48 hours and clinically deemed ready for planned extubation.

Exclusion criteria

Exclusion criteria: 1. Pre-existing vocal cord or upper airway anomalies 2. Suspected upper airway trauma or injury 3. Neuromuscular conditions (e.g., pseudobulbar/bulbar palsy) 4. Use of high-dose corticosteroids in prior 72 hours (prednisone more than or equal to 2 mg/kg/day or equivalent) 5. Ongoing pneumothorax with air leak 6. Tracheostomy in place 7. Imminent death or palliative care 8. Prior enrolment in this study 9. Withdrawal or refusal of consent

Design outcomes

Primary

MeasureTime frame
Incidence of reintubation or emergency surgical airway with Westley score greater than or equal to 8 with at least 1 point for stridorTimepoint: 72 hours

Secondary

MeasureTime frame
Incidence of clinically significant PEAO requiring medical interventionTimepoint: 72 hours;Length of PICU stay post-extubationTimepoint: At discharge from PICU;Extra days of invasive mechanical ventilation due to failed CLTTimepoint: At discharge from PICU;Incidence of ventilator associated pneumonia in the extra days of IMV due to failed CLTTimepoint: At discharge from PICU;Predictive value of air leak percentage for incidence of reintubation & clinically significant PEAOTimepoint: Just before extubation;Predictive value of peritubal free space measured by ultrasound for the incidence of reintubation & clinically significant PEAOTimepoint: Just before extubation

Countries

India

Contacts

Public ContactSagar S Kamat

AIIMS Raipur

dratuljindal@gmail.com8224014667

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026