Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid
NCT ID: NCT04076189
Last Updated: 2020-04-06
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-09-16
2019-09-24
Brief Summary
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Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.
Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.
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Detailed Description
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Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.
Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Endotracheal suctioning
Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation
Endotracheal suctioning
Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation
No endotracheal suctioning
Procedure includes: Initiation of positive pressure ventilation without endotracheal suctioning
No endotracheal suctioning
Procedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning
Interventions
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Endotracheal suctioning
Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation
No endotracheal suctioning
Procedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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University of Padova
OTHER
University Hospital Padova
OTHER
Responsible Party
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Daniele Trevisanuto
Clinical Professor
Locations
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Azienda Ospedaliera di Padova, University of Padova
Padua, , Italy
University of Padova
Padua, , Italy
Countries
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References
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Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
Chettri S, Adhisivam B, Bhat BV. Endotracheal Suction for Nonvigorous Neonates Born through Meconium Stained Amniotic Fluid: A Randomized Controlled Trial. J Pediatr. 2015 May;166(5):1208-1213.e1. doi: 10.1016/j.jpeds.2014.12.076. Epub 2015 Feb 4.
Nangia S, Sunder S, Biswas R, Saili A. Endotracheal suction in term non vigorous meconium stained neonates-A pilot study. Resuscitation. 2016 Aug;105:79-84. doi: 10.1016/j.resuscitation.2016.05.015. Epub 2016 May 30.
Chiruvolu A, Miklis KK, Chen E, Petrey B, Desai S. Delivery Room Management of Meconium-Stained Newborns and Respiratory Support. Pediatrics. 2018 Dec;142(6):e20181485. doi: 10.1542/peds.2018-1485. Epub 2018 Nov 1.
Other Identifiers
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UHPadova02/2019
Identifier Type: -
Identifier Source: org_study_id
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