Study to evaluate peri-operative problems of upper airway in children undergoing repair of cleft lip and palate.

Completed

• Conditions: Cleft Lip and or Palate children

• Registration Number: CTRI/2018/03/012443
• Lead Sponsor: Postgraduate Institute of Medical Education and Research PGIMER Chandigarh

Brief Summary

we propose to undertake a study to evaluate the airway in infants and children scheduled for cleft lip palate repair involving clinical and ultrasonography measurements to document the changes that occur in tongue thickness after repair of cleft palate.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Study Completion: 2016-10-31
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children with cleft lip or palate- unilateral or bilateral.
• Age 0-12 yrs 3.
• ASA I and ASA II 4.
• Scheduled for elective repair of lip and/or palate under GA.
• Children with or without obvious external anatomical variations.

Exclusion Criteria

Severe cardiac or respiratory co-morbidity 2.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the thickness of tongue, pre-repair and post-repair, ultrasonographically.	After induction(before intubation) and after extubation

Secondary Outcome Measures

Name	Time	Method
To assess the incidence of pre-opeprative and post-operative airway compromise in CLP children	Peri-operative period(until 2 hours after surgery).
Airway assessment including measurements of airway distance viz. sternomental distance,thyromental distance,and mentohyoid distance.	Pre-operatively in the ward(one day before surgery).

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Ratna Kumar

Principal investigator

9592914802

ratnakumar4802@gmail.com