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HypoxiaNCT02437864

Apneic Oxygenation During Airway Management in Pediatric Patients

A study testing Supplemental oxygen via nasal cannula in people with Hypoxia, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 8 years
Conditions the study is for
Hypoxia
What is being tested?
Supplemental oxygen via nasal cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteUnited States
Study dates
May 2015to Aug 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico Children's Hospital

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: Effect of Peri-intubation Apneic Oxygenation Via Nasal Cannula on Pediatric Patients' Oxygen Saturation During Airway Management

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.

Read the 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.

Conditions
Hypoxia
Being tested
Supplemental oxygen via nasal cannula
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supplemental oxygen via nasal cannulaDevice

Study groups in NCT02437864
Study groupRoleWhat they receive
Baseline GroupNo interventionAirway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
With-Cannula GroupExperimentalAirway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Receives: Device: Supplemental oxygen via nasal cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement

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

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

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

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

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

  4. Patients' Lowest Pulse Oximetry Value Observed During Airway Placement

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMar 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437864
Sponsor's protocol ID
14-307
Status last verified
Sep 2018
First submitted
30 Apr 2015
Last updated
17 Sep 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Supplemental oxygen via nasal cannula in people with Hypoxia, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Event: Pulse Oximetry at 95%, or Successful Intubation (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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