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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD103927 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Children's Hospital of Philadelphia | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apneic Oxygenation | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apneic Oxygenation | Procedure | Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Clinical Outcome: Change in Oxygen Saturation (SpO2) | Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter. | During intubation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Clinical Outcome: Severe oxygen desaturation | ≥20% decline in SpO2 | During intubation procedure |
| Secondary Clinical Outcome: SpO2<80% | SpO2<80% at any point |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: Cardiopulmonary resuscitation | Chest compressions with or without epinephrine | During or within 1 hour of procedure |
| Safety Outcome: Air Leaks | New pneumothorax |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Foglia, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26583943 | Background | Di Fiore JM, Poets CF, Gauda E, Martin RJ, MacFarlane P. Cardiorespiratory events in preterm infants: interventions and consequences. J Perinatol. 2016 Apr;36(4):251-8. doi: 10.1038/jp.2015.165. Epub 2015 Nov 19. | |
| 20304417 | Background | Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20. |
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The PI will make data available after study completion and in accordance with NIH policies. Our data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the institution's IRB or demonstration of IRB exemption per institutional policy. The data and the associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
After study completion.
Data use agreement in place prior to data sharing.
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Parallel group open-label randomized controlled trial.
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| Standard of Care | Procedure | No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care) |
|
| During intubation procedure |
| Secondary Clinical Outcome: Time to SpO2 <80% | Time to SpO2 <80% from facemask removal | During intubation procedure |
| Secondary Clinical Outcome: intubation success | First intubation attempt success | During intubation procedure |
| Secondary Clinical Outcome: Number of intubation attempts | Total number of intubation attempts | During intubation procedure |
| Secondary Clinical Outcome: Duration of intubation attempts | Duration of each intubation attempt | During intubation procedure |
| Secondary Clinical Outcome: Change in pulse rate | Difference between highest and lowest pulse rate | During intubation procedure |
| Secondary Clinical Outcome: pH | First blood gas pH | Three hours after intubation |
| Secondary Clinical Outcome: pCO2 | First blood gas pCO2 | Three hours after intubation |
| Secondary Clinical Outcome: PaO2 | First blood gas PaO2 (for infants with indwelling arterial lines) | Three hours after intubation |
| Feasibility Outcome: AO fidelity | Proportion subjects allocated to AO successfully provided the AO intervention | During the intubation procedure |
| Feasibility Outcome: Protocol deviations | Number of protocol deviations and violations | During intubation procedure |
| Feasibility Outcome: Screening | Proportion of intubated infants successfully screened in advance | Through study completion, an average of 18 months. |
| Feasibility Outcome: Recruitment | Rates of informed consent | Through study completion, an average of 18 months. |
| Feasibility Outcome: Randomization | Proportion of consented infants who were randomized | Through study completion, an average of 18 months. |
| Within 24 hours of procedure |
| Safety Outcome: Nasal Trauma | New nasal trauma | Within 24 hours of procedure |
| Safety Outcome: adverse Tracheal Intubation Adverse Events | Tracheal Intubation Adverse Events, per NEAR4NEOS definitions | During Intubation Procedure |
| Safety Outcome: Duration of time with 100% SpO2 | Duration of time with SpO2=100% | During Intubation Procedure |
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| 23562374 | Background | Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3. |
| 29715354 | Background | Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708. |
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| 37055198 | Derived | Herrick HM, O'Reilly M, Lee S, Wildenhain P, Napolitano N, Shults J, Nishisaki A, Foglia EE. Providing Oxygen during Intubation in the NICU Trial (POINT): study protocol for a randomised controlled trial in the neonatal intensive care unit in the USA. BMJ Open. 2023 Apr 13;13(4):e073400. doi: 10.1136/bmjopen-2023-073400. |