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

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

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

Study Overview

• Status: Completed
• Conditions: Techniques of Endotracheal Intubation in Pediatrics
• Intervention / Treatment: Procedure: Blind tracheal intubation through AirQ; Procedure: Fiberscopic tracheal intubation through AirQ

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Enas A Abd el Motlb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Blind tracheal intubation through AirQ; Patients were intubated through the air-Q blindly	Procedure: Blind tracheal intubation through AirQ; underwent blind intubation with correction manoeuvres
PLACEBO_COMPARATOR: Fiberscopic tracheal intubation through AirQ; Patients were intubated through the air-Q using fibreoptic bronchoscope	Procedure: Fiberscopic tracheal intubation through AirQ; : underwent fibreoptic guided intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The first trial success rate	percentage of cases of successful tracheal intubation during the first trial	during first trial of intubation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
Heart rate		After induction of anesthesia till 10 minutes after intubation
Mean arterial blood pressure		After induction of anesthesia till 10 minutes after intubation
blood staining of the device		from extubation till 24 hours after extubation
post-intubation croup		from extubation till 24 hours after extubation
hoarsenes	and its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)	from extubation till 24 hours after extubation

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation
• Other Study ID Numbers: R/17.11.129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No