Videolaryngoscopic versus Direct Laryngoscopic Paraglossal Intubation for Cleft Lip/Palate Reconstructive Surgeries.

Not yet recruiting

• Conditions: Cleft lipCleft palate

• Registration Number: CTRI/2018/01/011321
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

This study will be a randomized control trialconducted in the Post Graduate Institute of Medical Education and Research,Chandigarh between January, 2018 and October 2018. It will include paediatricin-patients with uncorrected cleft lip/palate posted for elective reconstruction surgeries. The sample size of 80 will be block randomized into 20 groups of 4 each.It will compare the reduction in difficult laryngoscopy performed by the paraglossal technique using the Videolaryngoscope versus the direct laryngoscope. The primary outcome will be to assess the first pass intubation rate using thevideolaryngoscope versus the direct laryngoscope in intubating by the leftparaglossal approach. The secondary outcomes will be to assess the time taken for successfulendotracheal intubation and the intubation difficulty score.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Last Update Posted: 2018-12-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with uncorrected cleft lip/palate.
• Patients posted for elective cleft lip/palate reconstructive surgery.

Exclusion Criteria

• Parents/guardians who do not give consent.
• Patients who have difficulat bag and mask ventilation.
• Patients with supraglottic mass lesions.
• Patients with hemodynamic instability.
• Patients with recent upper respiratory tract infections.
• Patients with coagulation disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate.	To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate after confirmation of successful endotracheal intubation by waveform capnography.

Secondary Outcome Measures

Name	Time	Method
Time taken for successful endotracheal intubation	Time taken from removal of facemask to confirmation of correct endotracheal tube placement by waveform capnography.
Intubation difficulty score	During laryngoscopy and post intubation.

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Ananya Ray

Principal investigator

9946606752

ananyaray1812@hotmail.com