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

Study Overview
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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.

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

Conditions
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Techniques of Endotracheal Intubation in Pediatrics

Intervention / Treatment
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* Procedure: Blind tracheal intubation through AirQ
* Procedure: Fiberscopic tracheal intubation through AirQ


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blind tracheal intubation through AirQ<br>Patients were intubated through the air-Q blindly | Procedure: Blind tracheal intubation through AirQ<br>* underwent blind intubation with correction manoeuvres<br>|
| Placebo Comparator: Fiberscopic tracheal intubation through AirQ<br>Patients were intubated through the air-Q using fibreoptic bronchoscope | Procedure: Fiberscopic tracheal intubation through AirQ<br>* : underwent fibreoptic guided intubation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation