Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

Surgery Clinical Trial

Official title:

Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06232915
• Other study ID #: STUDY00003946
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: February 2026

Study information

• Verified date: January 2024
• Source: Nationwide Children's Hospital
• Contact: Julie Rice-Weimer, RN
• Phone: 6143553142
• Email: julie.rice-weimer[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Pressure High
• Surgery

Intervention

Procedure:
• Mechanical ventilation
Mechanical ventilation during surgery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean inspired tidal volume	The average volume of air moved into the lungs over 25 breaths.	Baseline
Primary	Mean expired tidal volume	The average volume of air moved out of the lungs over 25 breaths.	Baseline