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Apneic Oxygenation During Airway Management in Pediatric Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02437864
Enrollment
360
Registered
2015-05-08
Start date
2015-05-31
Completion date
2018-08-31
Last updated
2018-09-17

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

Conditions

Hypoxia

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.

Interventions

DEVICESupplemental oxygen via nasal cannula

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to First Event: Pulse Oximetry at 95%, or Successful IntubationFrom anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of less than 10 minutesPrior 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

MeasureTime frame
Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway PlacementFrom anesthetic induction to intubation; an expected average of 10 minutes
Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway PlacementFrom anesthetic induction to intubation; an expected average of 10 minutes
Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway PlacementFrom anesthetic induction to intubation; an expected average of 10 minutes
Patients' Lowest Pulse Oximetry Value Observed During Airway PlacementFrom anesthetic induction to intubation; an expected average of 10 minutes

Countries

United States

Participant flow

Participants by arm

ArmCount
Baseline Group
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
196
With-Cannula Group
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula. Supplemental oxygen via nasal cannula
160
Total356

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation40

Baseline characteristics

CharacteristicBaseline GroupWith-Cannula GroupTotal
Age, Categorical
<=18 years
196 Participants160 Participants356 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous3 years2 years3 years
Body Mass Index (BMI)16.6 kg/m^216.3 kg/m^216.4 kg/m^2
Height95.3 centimeters89.3 centimeters92.5 centimeters
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
196 participants160 participants356 participants
Sex: Female, Male
Female
87 Participants67 Participants154 Participants
Sex: Female, Male
Male
109 Participants93 Participants202 Participants
Weight13.9 kilograms13.4 kilograms13.6 kilograms

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2000 / 160
other
Total, other adverse events
0 / 2000 / 160
serious
Total, serious adverse events
0 / 2000 / 160

Outcome results

Primary

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.

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

ArmMeasureValue (MEDIAN)
Baseline GroupTime to First Event: Pulse Oximetry at 95%, or Successful Intubation106 seconds
With-Cannula GroupTime to First Event: Pulse Oximetry at 95%, or Successful Intubation169 seconds
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline GroupNumber of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement52 Participants
With-Cannula GroupNumber of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement22 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline GroupNumber of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement61 Participants
With-Cannula GroupNumber of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement7 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline GroupNumber of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement85 Participants
With-Cannula GroupNumber of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement14 Participants
Secondary

Patients' Lowest Pulse Oximetry Value Observed During Airway Placement

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

ArmMeasureValue (MEDIAN)
Baseline GroupPatients' Lowest Pulse Oximetry Value Observed During Airway Placement97 percentage of oxygenated hemoglobin
With-Cannula GroupPatients' Lowest Pulse Oximetry Value Observed During Airway Placement99 percentage of oxygenated hemoglobin

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