Health Condition 1: Q320- Congenital tracheomalacia Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Supraglottoplasty: Under general anesthesia, using LASER/ cold steel instruments, addressing prolapsing supraglottic structures including either of epiglottopexy, aryepiglottoplasty, ar
Sponsors
All India Institute of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Laryngeal/ tracheal narrowing due to external compression Patients not consenting for surgery Severe neurological/ cardiac comorbidities / poor pulmonary reserve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. Effect on overall clinical status related to laryngotracheomalacia i) Frequency of hospitalizations 1 month before and after procedure 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
| Measure | Time frame |
|---|---|
| 1. Direct evidence of effect clinical parameters i) Grading of stridor based on appearance in breathing cycle ii) Oxygen saturation levels, heart rate , respiratory rate 2. Indirect evidence of effect of surgical intervention on clinical parameters i) Change in weight- weight gain/ change in z score using WHO growth chart ii) Parental perspective on effect on symptomsTimepoint: 1 month | — |
Countries
India
Contacts
Public ContactPrem Sagar
All India Institute of Medical Sciences
Outcome results
None listed