Surgical Procedures, OperativeNCT02768831
ETT Cuff Leak: TV Ratios
A study testing CPAP and Tidal volume in people with Surgical Procedures, Operative, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Procedures, Operative
- What is being tested?
- CPAP and Tidal volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 28 Jun 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children who are scheduled to undergo GA with a cuffed ETT in place.
Who cannot join
- Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal
In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.
- Conditions
- Surgical Procedures, Operative
- Being tested
- CPAP, Tidal volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPOther
Sealing the airway by holding CPAP of 20 cmH2O in the anesthesia circuit and slowly inflating the cuff until no air leak is heard with a stethoscope placed in the suprasternal notch.
Tidal volumeOther
Also called TV
The ratio of the inspired to expired tidal volume will be determined using the following formula: (TVinspired - TV¬expired)/TVinspired. The peak inflating pressure (PIP) required to achieve the set TV will be noted. The air in the cuff will then be increased or decreased as needed to achieve a set delivered ratio of 0.9-1.0.
| Study group | Role | What they receive |
|---|---|---|
| Cuffed ETT | Experimental | Not described Receives: Other: CPAP; Other: Tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff pressure
Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.
Measured: Immediately following intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start17 Aug 2020
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedures, OperativeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senthil G. Krishna, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768831
- Sponsor's protocol ID
- IRB16-00222
- Status last verified
- Jun 2024
- First submitted
- 10 May 2016
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moon K, Kitio SAY, Rice-Weimer J, Tobias JD. Regulation of Intracuff Pressure by Measurement of the Ratio of Expiratory to Inspiratory Tidal Volumes. Paediatr Anaesth. 2025 Nov;35(11):940-945. doi: 10.1111/pan.70045. Epub 2025 Sep 5.
PubMed 40913357
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal
- ClinicalTrials.gov ID
- NCT02768831
- Acronym / sponsor ID
- IRB16-00222
- Conditions
- Surgical Procedures, Operative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cuffed ETT | Experimental | Other: CPAP, Other: Tidal volume |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children who are scheduled to undergo GA with a cuffed ETT in place.
Key exclusion criteria (1 listed)
- Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.
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 |
|---|---|---|
| CPAPSealing the airway by holding CPAP of 20 cmH2O in the anesthesia circuit and slowly inflating the cuff until no air leak is heard with a stethoscope placed in the suprasternal notch. | Other | Cuffed ETT |
| Tidal volumeAlso: TVThe ratio of the inspired to expired tidal volume will be determined using the following formula: (TVinspired - TV¬expired)/TVinspired. The peak inflating pressure (PIP) required to achieve the set TV will be noted. The air in the cuff will then be increased or decreased as needed to achieve a set delivered ratio of 0.9-1.0. | Other | Cuffed ETT |
Primary outcome
Intracuff pressure
Time frame: Immediately following intubation
Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 40913357Moon K, Kitio SAY, Rice-Weimer J, Tobias JD. Regulation of Intracuff Pressure by Measurement of the Ratio of Expiratory to Inspiratory Tidal Volumes. Paediatr Anaesth. 2025 Nov;35(11):940-945. doi: 10.1111/pan.70045. Epub 2025 Sep 5.
Related trials for Surgical Procedures, Operative
Not yet recruiting
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
Recurrent Glioma (Glioblastoma Multiforme)
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
RecruitingObservational study
Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome
Familial Cancer, BRCA1-Associated Protein-1 (BAP1) Mutations
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?
A study testing CPAP and Tidal volume in people with Surgical Procedures, Operative, run by Nationwide Children's Hospital 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: finished, as of the sponsor's last update on 21 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intracuff pressure (time frame: Immediately following intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02768831, which also lists 1 linked publication.
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 21 Jun 2024.