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Completed

NCT Number: NCT05451953

Providing Oxygen During Intubation in the NICU Trial

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.

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Key information

Conditions

Neonatal Respiratory Failure Tracheal Intubation Morbidity

Age range

0 day–365 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants ≥28 weeks corrected gestational age
  • Undergoing intubation in the NICU
  • Pre-medication (including paralytic) administered

Exclusion criteria

  • Critical Airway or Airway Anomaly
  • Unstable hemodynamics (i.e. active resuscitation)
  • Unable to achieve SpO2 ≥90% prior to intubation attempt
  • Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
  • Unrepaired congenital diagrammatic hernia
  • Tracheal esophageal fistula within 2 weeks of repair
  • Tracheostomy
  • Previous enrollment in the trial
  • Nasal intubation
  • COVID person under investigation (PUI) or COVID positive
  • Cyanotic heart disease
  • Receiving Extracorporeal Membrane Oxygenation support
  • Conjoined twins

Treatment and study plan

Apneic oxygenation

Procedure

Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)

Standard of care

Procedure

No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)

Primary outcomes

  1. Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)

    Time frame: During intubation procedure

    Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.

Secondary outcomes

  1. Secondary Clinical Outcome: Severe oxygen desaturation

    Time frame: During intubation procedure

    ≥20% decline in SpO2

  2. Secondary Clinical Outcome: SpO2<80%

    Time frame: During intubation procedure

    SpO2<80% at any point

  3. Secondary Clinical Outcome: Time to SpO2 <80%

    Time frame: During intubation procedure

    Time to SpO2 <80% from facemask removal

  4. Secondary Clinical Outcome: intubation success

    Time frame: During intubation procedure

    First intubation attempt success

  5. Secondary Clinical Outcome: Number of intubation attempts

    Time frame: During intubation procedure

    Total number of intubation attempts

  6. Secondary Clinical Outcome: Duration of intubation attempts

    Time frame: During intubation procedure

    Duration of each intubation attempt

  7. Secondary Clinical Outcome: Change in pulse rate

    Time frame: During intubation procedure

    Difference between highest and lowest pulse rate

  8. Secondary Clinical Outcome: pH

    Time frame: Three hours after intubation

    First blood gas pH

  9. Secondary Clinical Outcome: pCO2

    Time frame: Three hours after intubation

    First blood gas pCO2

  10. Secondary Clinical Outcome: PaO2

    Time frame: Three hours after intubation

    First blood gas PaO2 (for infants with indwelling arterial lines)

  11. Feasibility Outcome: AO fidelity

    Time frame: During the intubation procedure

    Proportion subjects allocated to AO successfully provided the AO intervention

  12. Feasibility Outcome: Protocol deviations

    Time frame: During intubation procedure

    Number of protocol deviations and violations

  13. Feasibility Outcome: Screening

    Time frame: Through study completion, an average of 18 months.

    Proportion of intubated infants successfully screened in advance

  14. Feasibility Outcome: Recruitment

    Time frame: Through study completion, an average of 18 months.

    Rates of informed consent

  15. Feasibility Outcome: Randomization

    Time frame: Through study completion, an average of 18 months.

    Proportion of consented infants who were randomized

Other outcomes

  1. Safety Outcome: Cardiopulmonary resuscitation

    Time frame: During or within 1 hour of procedure

    Chest compressions with or without epinephrine

  2. Safety Outcome: Air Leaks

    Time frame: Within 24 hours of procedure

    New pneumothorax

  3. Safety Outcome: Nasal Trauma

    Time frame: Within 24 hours of procedure

    New nasal trauma

  4. Safety Outcome: adverse Tracheal Intubation Adverse Events

    Time frame: During Intubation Procedure

    Tracheal Intubation Adverse Events, per NEAR4NEOS definitions

  5. Safety Outcome: Duration of time with 100% SpO2

    Time frame: During Intubation Procedure

    Duration of time with SpO2=100%

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

Acronym: POINT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2022
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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