Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway

Not Applicable

Completed

• Conditions: Techniques of Endotracheal Intubation in Pediatrics
• Interventions: Procedure: Blind tracheal intubation through AirQ; Procedure: Fiberscopic tracheal intubation through AirQ

• Registration Number: NCT03778762
• Lead Sponsor: Mansoura University

Brief Summary

To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients

Detailed Description

A prior G-power analysis was done to estimate the sample size. The primary outcome of this study was the first trial success rate. Using fibre exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of cases was expected; therefore 63 patients were required in each group to detect the difference.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-30
• Status Verified: 2018-12
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-17
• Last Update Submitted: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• American Society of Anesthesiologists physical status I-II
• Body weight from 4 to 30 kg

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Exclusion Criteria

• Obesity
• History of gastroesophageal reflux
• History of hyperactive airway
• Patients with congenital disorders associated with difficult airway

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blind tracheal intubation through AirQ	Blind tracheal intubation through AirQ	Patients were intubated through the air-Q blindly
Fiberscopic tracheal intubation through AirQ	Fiberscopic tracheal intubation through AirQ	Patients were intubated through the air-Q using fibreoptic bronchoscope

Primary Outcome Measures

Name	Time	Method
The first trial success rate	during first trial of intubation procedure	percentage of cases of successful tracheal intubation during the first trial

Secondary Outcome Measures

Name	Time	Method
blood staining of the device	from extubation till 24 hours after extubation
The total success rate	from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure	percentage of cases underwent successful tracheal intubation during either first or second trial
Mean arterial blood pressure	After induction of anesthesia till 10 minutes after intubation
post-intubation croup	from extubation till 24 hours after extubation
hoarsenes	from extubation till 24 hours after extubation	and its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)
Time to ventilation	procedure (Time from beginning of air-Q insertion till full capno-graphic wave)	time needed to get full capno-graphic waves through connection of air Q to breathing circuit
Time to intubation	procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)	time needed to get full capno-graphic waves through connection of endotracheal tube to breathing circuit
Heart rate	After induction of anesthesia till 10 minutes after intubation

Trial Locations

Locations (1)

Enas A Abd el Motlb; 🇪🇬 Mansourah, DK, Egypt