ClinicalTrials.gg
CompletedNCT03823716Updated Feb 17, 2020

Inadvertent Hyperventilation During Intraoperative Care in Neonates

An observational study in Neonatal Disorder, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Nationwide Children's Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
112
Ages
Up to 36 Weeks
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 43 studies in Infant, Newborn, Diseases with a site in United States — 3 open to participants now, 7 under way, 1 of them phase 3. Infant, Newborn, Diseases · United States.

Started
2017
with 3 others
Observational
9 of 43
none open now
Registered
34th of 43
by date

Among the 43 studies in Infant, Newborn, Diseases with a site in United States, this one is one of 4 that started in 2017, is one of 9 observational ones, and was the 34th registered.

Infant, Newborn, Diseases

140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.

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Open to participants now

3 of the 43 studies in Infant, Newborn, Diseases with a site in United States are open now. Recruiting first, the newest first:

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A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 21 Infant, Newborn, Diseases studies recruiting now, 3 (14%) set no upper age limit and 18 (86%) stop at 75 or younger; 17 take children under 18; 5 take healthy volunteers.

This study: Up to 36 Weeks · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Neonatal Disorder
04

Who can participate

Ages eligible
Up to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients seen at Nationwide Children's Hospital.

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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

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
112 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Decreased Partial Pressure of Carbon Dioxide (PaCO2)

    PaCO2 from arterial blood gas (ABG) ≤ 35

    Time frame: During surgical procedure (average of 2-3 hours)

07

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
08

References and documents

Publications

  • 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. PubMed 32184375 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Nov 2019, 32 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2019
First posted
Jan 30, 2019
StartActual
Mar 1, 2017
Primary completionActual
Nov 8, 2019
CompletionActual
Nov 8, 2019
Last update
Feb 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03823716
Responsible party
Kristin Chenault (Clinical Assistant Professor of Anesthesiology, Nationwide Children's Hospital) — Principal investigator
First posted
Jan 30, 2019
Start date
Mar 1, 2017
Primary completion
Nov 8, 2019
Completion
Nov 8, 2019
Last update
Feb 17, 2020

Study contacts

Kristin Chenault, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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