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Clinical Trials/NCT06232915
NCT06232915
Withdrawn
N/A

Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

Joseph D. Tobias1 site in 1 country100 target enrollmentJune 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Surgery
Sponsor
Joseph D. Tobias
Enrollment
100
Locations
1
Primary Endpoint
Mean expired tidal volume
Status
Withdrawn
Last Updated
6 months ago

Overview

Brief Summary

Prior to surgery the anesthesia team will be putting a breathing tube into the patient's windpipe and attaching it to a mechanical ventilator (breathing machine). This is to provide oxygen and anesthetic gas, and to help the child breathe while they're asleep. The ventilator also controls the amount of air that moves in and out of the lungs with each breath. This is called tidal volume and that amount is programmed into the machine by the anesthesia team. All of this is standard of care.

As part of the study the investigators will put a small flow sensor between the patient's breathing tube and the tubing from the ventilator. This will measure the amount of air that is moving in and out of the breathing tube. The study team will record the tidal volume that is set on the ventilator and compare it to the airflow measured by the ventilator and the airflow measured by the sensor and see if there is a difference.

Registry
clinicaltrials.gov
Start Date
June 1, 2025
End Date
December 1, 2026
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Joseph D. Tobias
Responsible Party
Sponsor Investigator
Principal Investigator

Joseph D. Tobias

Chief, Dept. of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • children aged 0-18 years having surgery at Nationwide Children's Hospital, in whom a cuffed ETT and mechanical ventilation will be used

Exclusion Criteria

  • children with preexisting airway anomalies or respiratory compromise will be excluded from the study.

Outcomes

Primary Outcomes

Mean expired tidal volume

Time Frame: Baseline

The average volume of air moved out of the lungs over 25 breaths.

Mean inspired tidal volume

Time Frame: Baseline

The average volume of air moved into the lungs over 25 breaths.

Study Sites (1)

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