Apneic Oxygenation for Tracheal Intubation Morbidity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tracheal Intubation Morbidity+1 MoreApneic Oxygenation - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial will compare apneic oxygenation to standard care in order to determine if apneic oxygenation reduces oxygen desaturation during tracheal intubation in infants in the NICU.

Eligible Conditions
  • Tracheal Intubation Morbidity
  • Neonatal Respiratory Failure

Treatment Effectiveness

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Through study completion, an average of 18 months.

During Intubation Procedure
Safety Outcome: Duration of time with 100% SpO2
Intubation, Intratracheal
During intubation procedure
Feasibility Outcome: Protocol deviations
Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
Secondary Clinical Outcome: Change in pulse rate
Secondary Clinical Outcome: Duration of intubation attempts
Intubation (procedure)
Secondary Clinical Outcome: Severe oxygen desaturation
Saturation of Peripheral Oxygen
Secondary Clinical Outcome: Time to SpO2 <80%
Intubation (procedure)
Hour 1
Safety Outcome: Cardiopulmonary resuscitation
During the intubation procedure
Feasibility Outcome: AO fidelity
Three hours after intubation
Secondary Clinical Outcome: PaO2
Secondary Clinical Outcome: pCO2
Secondary Clinical Outcome: pH
Month 18
Feasibility Outcome: Randomization
Feasibility Outcome: Recruitment
Feasibility Outcome: Screening
Hour 24
Safety Outcome: Air Leaks
Safety Outcome: Nasal Trauma

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Apneic Oxygenation
1 of 2

Active Control

Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Apneic Oxygenation · No Placebo Group · N/A

Apneic Oxygenation
Procedure
Experimental Group · 1 Intervention: Apneic Oxygenation · Intervention Types: Procedure
Standard of Care
Procedure
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apneic Oxygenation
2017
N/A
~200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 18 months.

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,821 Previous Clinical Trials
2,238,026 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
1,840 Previous Clinical Trials
41,126,267 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
648 Previous Clinical Trials
7,849,328 Total Patients Enrolled
Elizabeth Foglia, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are ≥28 weeks gestation.
References