Inadvertent Hyperventilation During Intraoperative Care in Neonates

Neonatal Disorder Clinical Trial

Official title:

Inadvertent Hyperventilation During Intraoperative Care in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823716
• Other study ID #: IRB17-00032
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: November 8, 2019

Study information

• Verified date: February 2020
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Hyperventilation
• Infant, Newborn, Diseases
• Neonatal Disorder

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased Partial Pressure of Carbon Dioxide (PaCO2)	PaCO2 from arterial blood gas (ABG) = 35	During surgical procedure (average of 2-3 hours)