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

Mansoura University

Status: Completed

Conditions: Techniques of Endotracheal Intubation in Pediatrics

Treatments: Procedure: Blind tracheal intubation through AirQ; Procedure: Fiberscopic tracheal intubation through AirQ

Study type: Interventional

Funder types: Other

Identifiers

NCT03778762

R/17.11.129

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups, including a placebo group

Blind tracheal intubation through AirQ

Active Comparator group

Description:

Patients were intubated through the air-Q blindly

Treatment:

Procedure: Blind tracheal intubation through AirQ

Fiberscopic tracheal intubation through AirQ

Placebo Comparator group

Description:

Patients were intubated through the air-Q using fibreoptic bronchoscope

Treatment:

Procedure: Fiberscopic tracheal intubation through AirQ