A study to evaluate the effect of widening of upper airway on lower airway obstructio
- Conditions
- Health Condition 1: Q320- Congenital tracheomalaciaHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2023/06/054248
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Age group of 1 month - 5 years with noisy breathing/stridor
Endoscopic confirmation of co-existing laryngomalacia and tracheomalacia
More than 50% collapse in the trachea during expiration / inspiration on dynamic flexible bronchoscopy.
Any degree of laryngomalacia
Presence of at least two of the following clinical features
1. Failure to thrive (z-score of weight for age less than 2)
2. 3 or more hospitalizations for LTM related complications
3. Severe respiratory distress necessitating endotracheal intubation
4. Episodes of bradycardia/ cyanosis/ apnea due to Laryngotracheomalacia
5. SPO2 less than 90% at room air without the support of O2/ CPAP
6. Previously tracheostomized for LTM with failed attempts at decannulation
Parents giving informed written consent to participate in the study.
Laryngeal/ tracheal narrowing due to external compression
Patients not consenting for surgery
Severe neurological/ cardiac comorbidities / poor pulmonary reserve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in severity of tracheomalacia (bronchoscopic assessment of site of airway collapse, degree of airway collapse and duration of collapse in relation to breathing cycle) after 1 month post surgery <br/ ><br>2. Effect on overall clinical status related to laryngotracheomalacia <br/ ><br>i) Frequency of hospitalizations 1 month before and after procedure <br/ ><br>ii) Frequency of life threatening events (cyanotic spells/ acute respiratory distress/ bradycardia/ apnoea/ hypoxia) in 1 month after post operativeTimepoint: 1 month post operative
- Secondary Outcome Measures
Name Time Method 1. Direct evidence of effect clinical parameters <br/ ><br>i) Grading of stridor based on appearance in breathing cycle <br/ ><br>ii) Oxygen saturation levels, heart rate , respiratory rate <br/ ><br>2. Indirect evidence of effect of surgical intervention on clinical parameters <br/ ><br>i) Change in weight- weight gain/ change in z score using WHO growth chart <br/ ><br>ii) Parental perspective on effect on symptomsTimepoint: 1 month