Enas A Abd el Motlb
Al Mansurah, DK, 050, Egypt
Completed
NCT Number: NCT03778762
Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway
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
Completed
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Notify MeKey information
Age range
2 year–10 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Blind tracheal intubation through AirQ
Procedureunderwent blind intubation with correction manoeuvres
Fiberscopic tracheal intubation through AirQ
Procedure: underwent fibreoptic guided intubation
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
-
The total success rate
Time frame: from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure
percentage of cases underwent successful tracheal intubation during either first or second trial
-
Time to ventilation
Time frame: procedure (Time from beginning of air-Q insertion till full capno-graphic wave)
time needed to get full capno-graphic waves through connection of air Q to breathing circuit
-
Time to intubation
Time frame: procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)
time needed to get full capno-graphic waves through connection of endotracheal tube to breathing circuit
-
Heart rate
Time frame: After induction of anesthesia till 10 minutes after intubation
-
Mean arterial blood pressure
Time frame: After induction of anesthesia till 10 minutes after intubation
-
blood staining of the device
Time frame: from extubation till 24 hours after extubation
-
post-intubation croup
Time frame: from extubation till 24 hours after extubation
-
hoarsenes
Time frame: from extubation till 24 hours after extubation
and its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)
Sponsors and collaborators
Lead sponsor
Mansoura University
Other
Registry information
Official study title
Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Dec 19, 2018
- Registry last updated
- Dec 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.