Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

NCT ID: NCT06232915

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-12-31

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.

Conditions

Surgery; Mechanical Ventilation Pressure High

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mechanical ventilation

Children requiring mechanical ventilation during a surgical procedure.

Mechanical ventilation

Intervention Type: PROCEDURE

Mechanical ventilation during surgery

Interventions

Mechanical ventilation

Mechanical ventilation during surgery

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph D. Tobias

OTHER

Sponsor Role: lead

Responsible Party

Joseph D. Tobias

Chief, Dept. of Anesthesiology & Pain Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

STUDY00003946

Identifier Type: -

Identifier Source: org_study_id