NCT03823716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

January 23, 2019

Last Update Submit

February 14, 2020

Conditions

Neonatal Disorder

Outcome Measures

Primary Outcomes (1)

  • Decreased Partial Pressure of Carbon Dioxide (PaCO2)

    PaCO2 from arterial blood gas (ABG) ≤ 35

    During surgical procedure (average of 2-3 hours)

Eligibility Criteria

AgeUp to 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients seen at Nationwide Children's Hospital.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • Chenault K, Wakimoto M, Miller R, Tobias JD. The Incidence and Severity of Hypocarbia in Neonates Undergoing General Anesthesia. Respir Care. 2020 Aug;65(8):1154-1159. doi: 10.4187/respcare.07382. Epub 2020 Mar 17.

    PMID: 32184375DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kristin Chenault, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 30, 2019

Study Start

March 1, 2017

Primary Completion

November 8, 2019

Study Completion

November 8, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

US(1)