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Inadvertent Hyperventilation During Intraoperative Care in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823716
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kristin Chenault, Nationwide Children's Hospital

Brief Summary:
In order to evaluate current anesthetic practice in the care of preterm infants and neonates, the investigators will retrospectively review surgical procedures in infants who are less than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or in situ upon arrival in the operating room. They will evaluate the mode of ventilation (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP, inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to determine the average minute ventilation.

Condition or disease
Neonatal Disorder

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Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Inadvertent Hyperventilation During Intraoperative Care in Neonates
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : November 8, 2019



Primary Outcome Measures :
  1. Decreased Partial Pressure of Carbon Dioxide (PaCO2) [ Time Frame: During surgical procedure (average of 2-3 hours) ]
    PaCO2 from arterial blood gas (ABG) ≤ 35



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at Nationwide Children's Hospital.
Criteria

Inclusion Criteria:

  • neonates (<60 weeks post-conceptual age) undergoing non-cardiac operative procedures in which arterial access is generally present (exploratory laparotomy or thoracotomy)

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823716


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Kristin Chenault, MD Nationwide Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristin Chenault, Clinical Assistant Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03823716    
Other Study ID Numbers: IRB17-00032
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperventilation
Infant, Newborn, Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory