Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

NCT01664234 | Completed

• 1 other identifier: ECS 1178/2012
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Infants; Difficult Airway

Keywords

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

Outcome Measures

Primary Outcomes (1)

• time to oxygen saturation

  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.

  Day 1

Secondary Outcomes (1)

• mean oxygenation comparison

  Day 1

Study Arms (2)

laryngoscopy with simultaneous insufflation of oxygen

EXPERIMENTAL

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.

Other: laryngoscopy with oxygen

laryngoscopy without simultaneous oxygen insufflation

PLACEBO COMPARATOR

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.

Other: laryngoscopy without oxygen

Interventions

laryngoscopy with oxygen OTHER

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.

laryngoscopy with simultaneous insufflation of oxygen

laryngoscopy without oxygen OTHER

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

laryngoscopy without simultaneous oxygen insufflation

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants (0-2) difficult airways

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medizinischen Universität Wien

Vienna, Borschkegasse, 1090, Austria

Location

MeSH Terms

Conditions

Pierre Robin Syndrome; Mandibulofacial Dysostosis; Down Syndrome

Interventions

Laryngoscopy; Oxygen

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniofacial Dysostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Coloboma; Eye Diseases, Hereditary; Eye Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Olga Plattner, M.D.

  Medizinischen Universität Wien Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 14, 2012
• Study Start: January 1, 2012
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2014
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

AU (1)