Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664234

Enrollment

Registered

2012-08-14

Start date

2012-01-01

Completion date

2014-12-30

Last updated

2023-08-31

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

Conditions

Difficult Airway, Infants

Keywords

infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21

Brief summary

Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.

Interventions

OTHERlaryngoscopy with oxygen

Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.

OTHERlaryngoscopy without oxygen

Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Months to 2 Years

Healthy volunteers

Inclusion criteria

* infants (0-2) difficult airways

Exclusion criteria

* . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting

Design outcomes

Primary

Measure	Time frame	Description
time to oxygen saturation	Day 1	The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.

Secondary

Measure	Time frame	Description
mean oxygenation comparison	Day 1	Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test

Countries

Austria

Outcome results

None listed

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