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

Techniques of Endotracheal Intubation in Pediatrics Clinical Trial

Official title:

Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778762
• Other study ID #: R/17.11.129
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 30, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I-II

• Body weight from 4 to 30 kg

Exclusion Criteria:

• Obesity

• History of gastroesophageal reflux

• History of hyperactive airway

• Patients with congenital disorders associated with difficult airway

Related Conditions & MeSH terms

• Techniques of Endotracheal Intubation in Pediatrics

Intervention

Procedure:
• Blind tracheal intubation through AirQ
underwent blind intubation with correction manoeuvres
• Fiberscopic tracheal intubation through AirQ
: underwent fibreoptic guided intubation

Locations

Country	Name	City	State
Egypt	Enas A Abd el Motlb	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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