Apneic Oxygenation During Airway Management in Pediatric Patients
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supplemental oxygen via nasal cannula
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients presenting for surgery at University of New Mexico Children's Hospital
- Age range: adjusted gestational age 40 weeks, to 8 years
Exclusion Criteria:
- Patients whose airways would be maintained with mask ventilation only
- American Society of Anesthesiologists classes 4-6
Sites / Locations
- University of New Mexico Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Baseline Group
With-Cannula Group
Arm Description
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement
Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement
Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement
Patients' Lowest Pulse Oximetry Value Observed During Airway Placement
Full Information
NCT ID
NCT02437864
First Posted
April 30, 2015
Last Updated
September 13, 2018
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT02437864
Brief Title
Apneic Oxygenation During Airway Management in Pediatric Patients
Official Title
Effect of Peri-intubation Apneic Oxygenation Via Nasal Cannula on Pediatric Patients' Oxygen Saturation During Airway Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This observational (i.e. nonrandomized) study aims to investigate the effect of a planned practice change; instituting oxygenation via nasal cannula during induction of anesthesia. The use of a nasal cannula during the peri-intubation period is of minimal risk and is not considered a standard of care in pediatric anesthesia. Some providers use it in certain clinical situations, but it is not broadly used and has virtually no pediatric literature to support or refute its use. At our institution, intubation of pediatric patients by inexperienced (learner) providers under expert supervision is routine. The attending physician intervenes if necessary before the patient experiences excessive loss of oxygenation.
Participants will be enrolled in the study once they have entered the pre-operative area and are determined by the attending anesthesiologist to be an eligible study participant. Participants enrolled in the first three months of the study (up to N=200) will be assigned to the baseline condition as described below. Participants enrolled in the second phase of the study (up to N=300) will be assigned to the with-cannula condition described below.
Apneic oxygenation is based on the physiology of the lungs: they absorb a greater volume of oxygen, 250 ml/min in an adult, than the volume of carbon dioxide, 8-20 mL/min, that is released by the lungs, because the majority of carbon dioxide is buffered in the blood stream during apnea. With the imbalanced volumes of absorption and release of gases in the lungs there is a lower than atmospheric pressure in the lungs, creating a passive movement of gases from pharynx to alveoli. If the gas in the pharynx has a significantly higher percentage of oxygen instead of room air at 21% oxygen, a higher amount of oxygen can be passively delivered to the lungs for absorption prolonging the time to hemoglobin desaturation.
For the Baseline Group of this observational (nonrandomized) study, all intubation procedures will be performed as per usual practice. Patients will receive premedication as determined by anesthesiologist/resident/midlevel. Once patients are brought to the operating room and vital signs are being monitored, patients will be preoxygenated via mask per standard of care, with an expired oxygenation concentration minimum of 0.75. Vitals will be recorded at the moment prior to removal of the face mask at the end of the preoxygenation period. Anesthetic induction will be performed with agents and dosages as per the provider's clinical judgment. Airway management consisting of oral endotracheal intubation or laryngeal mask airway insertion will take place. As per standard of care, an attending physician who is expert in pediatric airway management will supervise the procedure and intervene before the patient experiences excessive oxygen desaturation.
For the With-Cannula Group, all of the above steps will be maintained. The sole difference will be nasal cannula placement after induction. It will be set to deliver oxygen at 5 liters per minute. Airway management consisting of oral endotracheal intubation or laryngeal mask airway insertion will take place. As per standard of care, an attending physician who is expert in pediatric airway management will supervise the procedure and intervene before the patient experiences excessive oxygen desaturation.
Apneic oxygenation will not be used as a long-term oxygenation strategy. No patient will be allowed to become hypoxic for research reasons.
All intubation procedures in both study groups will proceed as per usual practice. The goal of all intubation procedures has always been and remains the maintenance of adequate oxygen saturation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline Group
Arm Type
No Intervention
Arm Description
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
Arm Title
With-Cannula Group
Arm Type
Experimental
Arm Description
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Intervention Type
Device
Intervention Name(s)
Supplemental oxygen via nasal cannula
Primary Outcome Measure Information:
Title
Time to First Event: Pulse Oximetry at 95%, or Successful Intubation
Description
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.
Time Frame
From anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of less than 10 minutes
Secondary Outcome Measure Information:
Title
Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement
Time Frame
From anesthetic induction to intubation; an expected average of 10 minutes
Title
Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement
Time Frame
From anesthetic induction to intubation; an expected average of 10 minutes
Title
Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement
Time Frame
From anesthetic induction to intubation; an expected average of 10 minutes
Title
Patients' Lowest Pulse Oximetry Value Observed During Airway Placement
Time Frame
From anesthetic induction to intubation; an expected average of 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients presenting for surgery at University of New Mexico Children's Hospital
Age range: adjusted gestational age 40 weeks, to 8 years
Exclusion Criteria:
Patients whose airways would be maintained with mask ventilation only
American Society of Anesthesiologists classes 4-6
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Codruta Soneru, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Children's Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
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Apneic Oxygenation During Airway Management in Pediatric Patients
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