CClinicalTrials.gg
WithdrawnNCT06232915Updated Oct 27, 2025

Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

An observational study in Surgery and Mechanical Ventilation Pressure High, sponsored by Joseph D. Tobias. Withdrawn at 1 site in United States. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-10-27.

Sponsored by Joseph D. Tobias · Observational

Why this study was withdrawn
Changed to an invitro study using a mechanical lung rather than human subjects.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Mechanical Ventilation Pressure High
03

In context

Lead sponsor

Joseph D. Tobias is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children requiring intraoperative mechanical ventilation.

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

Exclusion Criteria:

  • children with preexisting airway anomalies or respiratory compromise will be excluded from the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Mechanical ventilation

    Children requiring mechanical ventilation during a surgical procedure.

    Procedure: Mechanical ventilation

Interventions

  • ProcedureMechanical ventilation

    Mechanical ventilation during surgery

06

What researchers measure

Primary outcomes

  1. Mean inspired tidal volume

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

    Time frame: Baseline

  2. Mean expired tidal volume

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

    Time frame: Baseline

07

Study locations

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

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06232915
Lead sponsor
Joseph D. Tobias
Responsible party
Joseph D. Tobias (Chief, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Jan 31, 2024
Start date
Jun 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 27, 2025

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 withdrawn, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion