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

NCT ID: NCT03778762

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Techniques of Endotracheal Intubation in Pediatrics

Keywords

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air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Blind tracheal intubation through AirQ

Patients were intubated through the air-Q blindly

Group Type ACTIVE_COMPARATOR

Blind tracheal intubation through AirQ

Intervention Type PROCEDURE

underwent blind intubation with correction manoeuvres

Fiberscopic tracheal intubation through AirQ

Patients were intubated through the air-Q using fibreoptic bronchoscope

Group Type PLACEBO_COMPARATOR

Fiberscopic tracheal intubation through AirQ

Intervention Type PROCEDURE

: underwent fibreoptic guided intubation

Interventions

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Blind tracheal intubation through AirQ

underwent blind intubation with correction manoeuvres

Intervention Type PROCEDURE

Fiberscopic tracheal intubation through AirQ

: underwent fibreoptic guided intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enas A Abd el Motlb, MD

Role: STUDY_CHAIR

Associate Professor

Locations

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Enas A Abd el Motlb

Al Mansurah, DK, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R/17.11.129

Identifier Type: -

Identifier Source: org_study_id