Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- The first trial success rate
Study Overview
Brief 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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists physical status I-II
- •Body weight from 4 to 30 kg
Exclusion Criteria
- •History of gastroesophageal reflux
- •History of hyperactive airway
- •Patients with congenital disorders associated with difficult airway
Arms & Interventions
Blind tracheal intubation through AirQ
Patients were intubated through the air-Q blindly
Intervention: Blind tracheal intubation through AirQ (Procedure)
Fiberscopic tracheal intubation through AirQ
Patients were intubated through the air-Q using fibreoptic bronchoscope
Intervention: Fiberscopic tracheal intubation through AirQ (Procedure)
Outcomes
Primary Outcomes
The first trial success rate
Time Frame: during first trial of intubation procedure
percentage of cases of successful tracheal intubation during the first trial
Secondary Outcomes
- Time to ventilation(procedure (Time from beginning of air-Q insertion till full capno-graphic wave))
- Time to intubation(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)
- blood staining of the device(from extubation till 24 hours after extubation)
- The total success rate(from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure)
- Mean arterial blood pressure(After induction of anesthesia till 10 minutes after intubation)
- post-intubation croup(from extubation till 24 hours after extubation)
- hoarsenes(from extubation till 24 hours after extubation)