Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Mechanical Ventilation Pressure High
• Intervention / Treatment: Procedure: Mechanical ventilation

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Julie Rice-Weimer, RN; Phone Number: 6143553142; Email: julie.rice-weimer@nationwidechildrens.org
• Study Contact Backup: Name: Catherine Roth, MPH; Phone Number: 6147222997; Email: catherine.roth@nationwidechildrens.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children requiring intraoperative mechanical ventilation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanical ventilation; Children requiring mechanical ventilation during a surgical procedure.	Procedure: Mechanical ventilation; Mechanical ventilation during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean inspired tidal volume	The average volume of air moved into the lungs over 25 breaths.	Baseline
Mean expired tidal volume	The average volume of air moved out of the lungs over 25 breaths.	Baseline

Collaborators and Investigators

• Sponsor: Joseph D. Tobias

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No