Apneic Oxygenation During Airway Management in Pediatric Patients

NCT02437864 | Completed Results

• 1 other identifier: 14-307
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Airway placement after anesthetic induction in pediatric patients is routinely performed at our institution without apneic oxygenation. When intubation is attempted by an inexperienced (learner) provider, the attending physician intervenes if necessary before the patient experiences excessive loss of oxygenation. The investigators plan to institute routine supplemental oxygenation via nasal cannula during this placement. This study will examine the effect of adding apneic oxygenation via nasal cannula on oxygen saturation.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Time to First Event: Pulse Oximetry at 95%, or Successful Intubation

  Prior to anesthesia induction, patients are ventilated to achieve pulse oximetry (SpO2) values near 100%. This outcome represents the elapsed time before successful intubation or pulse oximetry declining to 95%, whichever came first.

  From anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of less than 10 minutes

Secondary Outcomes (4)

• Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement

  From anesthetic induction to intubation; an expected average of 10 minutes

• Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement

  From anesthetic induction to intubation; an expected average of 10 minutes

• Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement

  From anesthetic induction to intubation; an expected average of 10 minutes

• Patients' Lowest Pulse Oximetry Value Observed During Airway Placement

  From anesthetic induction to intubation; an expected average of 10 minutes

Study Arms (2)

Baseline Group

NO INTERVENTION

Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.

With-Cannula Group

EXPERIMENTAL

Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.

Device: Supplemental oxygen via nasal cannula

Interventions

Supplemental oxygen via nasal cannula DEVICE

With-Cannula Group

Eligibility Criteria

• Age: 1 Day - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients presenting for surgery at University of New Mexico Children's Hospital
• Age range: adjusted gestational age 40 weeks, to 8 years

You may not qualify if:

• Patients whose airways would be maintained with mask ventilation only
• American Society of Anesthesiologists classes 4-6

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Children's Hospital

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Codruta Soneru
• Organization: University of New Mexico Health Sciences Center (HSC)

csoneru@salud.unm.edu

5052722610

Study Officials

• Codruta Soneru, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 17, 2018
• Results First Posted: August 3, 2018

Record last verified: 2018-09

Locations

US (1)