SurgeryNCT06232915
Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation
An observational study of Surgery and Mechanical Ventilation Pressure High, run by Joseph D. Tobias at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Surgery, Mechanical Ventilation Pressure High
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children requiring intraoperative mechanical ventilation.
Who may be able to join
- children aged 0-18 years having surgery at Nationwide Children's Hospital, in whom a cuffed ETT and mechanical ventilation will be used
Who cannot join
- children with preexisting airway anomalies or respiratory compromise will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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
- Being tested
- Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationProcedure or surgery
Mechanical ventilation during surgery
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation | Children requiring mechanical ventilation during a surgical procedure. Receives: Procedure: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean inspired tidal volume
The average volume of air moved into the lungs over 25 breaths.
Measured: Baseline
Mean expired tidal volume
The average volume of air moved out of the lungs over 25 breaths.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Changed to an invitro study using a mechanical lung rather than human subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232915
- Sponsor's protocol ID
- STUDY00003946
- Status last verified
- Oct 2025
- First submitted
- 22 Jan 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06232915
- Acronym / sponsor ID
- STUDY00003946
- Conditions
- Surgery, Mechanical Ventilation Pressure High
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changed to an invitro study using a mechanical lung rather than human subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation | – | Procedure: Mechanical ventilationChildren requiring mechanical ventilation during a surgical procedure. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children requiring intraoperative mechanical ventilation.
Key inclusion criteria (1 listed)
- children aged 0-18 years having surgery at Nationwide Children's Hospital, in whom a cuffed ETT and mechanical ventilation will be used
Key exclusion criteria (1 listed)
- children with preexisting airway anomalies or respiratory compromise will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationMechanical ventilation during surgery | Procedure or surgery | Mechanical ventilation |
Primary outcome
Mean inspired tidal volume
Time frame: Baseline
The average volume of air moved into the lungs over 25 breaths.
Mean expired tidal volume
Time frame: Baseline
The average volume of air moved out of the lungs over 25 breaths.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Mechanical Ventilation Pressure High, run by Joseph D. Tobias at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean inspired tidal volume (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.