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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03778762
Enrollment
126
Registered
2018-12-19
Start date
2017-12-01
Completion date
2018-09-30
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Techniques of Endotracheal Intubation in Pediatrics

Keywords

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

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.

Interventions

PROCEDUREBlind tracheal intubation through AirQ

underwent blind intubation with correction manoeuvres

PROCEDUREFiberscopic tracheal intubation through AirQ

: underwent fibreoptic guided intubation

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The first trial success rateduring first trial of intubation procedurepercentage of cases of successful tracheal intubation during the first trial

Secondary

MeasureTime frameDescription
The total success ratefrom beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedurepercentage of cases underwent successful tracheal intubation during either first or second trial
Time to ventilationprocedure (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 intubationprocedure (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
hoarsenesfrom extubation till 24 hours after extubationand its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)
Mean arterial blood pressureAfter induction of anesthesia till 10 minutes after intubation
blood staining of the devicefrom extubation till 24 hours after extubation
post-intubation croupfrom extubation till 24 hours after extubation
Heart rateAfter induction of anesthesia till 10 minutes after intubation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026