One-lung Ventilation (OLV)NCT02424487
Intracuff Pressure During One-lung Ventilation in Infants and Children
An observational study of One-lung Ventilation (OLV), run by Joseph D. Tobias at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- One-lung Ventilation (OLV)
- What is being tested?
- Intracuff pressure measurement in one-lung ventilation during thoracic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 23 Feb 2018
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female from 0-18 years old having thoracic surgery and requiring one-lung ventilation.
Who may be able to join
- Patients 0-18 yars old.
- Patients requiring intubation with a cuffed specialized endotracheal tube or bronchial blocker.
- Patients having thoracic surgery.
- Patients that require one-lung ventilation (OLV).
Who cannot join
- Patients that do not require to have cuffed specialized endotracheal tube or bronchial blocker.
- Patients not requiring one-lung ventilation.
- Patients not having thoracic surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.
- Conditions
- One-lung Ventilation (OLV)
- Being tested
- Intracuff pressure measurement in one-lung ventilation during thoracic surgery
- Keywords
- Initial pressure, changes of intracuff pressure, infants and children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracuff pressure measurement in one-lung ventilation during thoracic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intracuff pressure during one-lung ventilation | Measurement of changes in intracuff pressure with one-lung ventilation during thoracic surgery. Receives: Procedure: Intracuff pressure measurement in one-lung ventilation during thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff pressure during OLV
Evaluate changes in intracuff pressure with OLV during thoracic surgery.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-lung Ventilation (OLV)Studies 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
- 30 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
- Investigators
- Joseph Tobias, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424487
- Sponsor's protocol ID
- IRB14-00826
- Status last verified
- Jan 2019
- First submitted
- 14 Nov 2014
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracuff Pressure During One-lung Ventilation in Infants and Children
- ClinicalTrials.gov ID
- NCT02424487
- Acronym / sponsor ID
- IRB14-00826
- Conditions
- One-lung Ventilation (OLV)
- Keywords
- Initial pressure, changes of intracuff pressure, infants and children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 23 Apr 2015 (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.
The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracuff pressure during one-lung ventilation | – | Procedure: Intracuff pressure measurement in one-lung ventilation during thoracic surgeryMeasurement of changes in intracuff pressure with one-lung ventilation during thoracic surgery. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female from 0-18 years old having thoracic surgery and requiring one-lung ventilation.
Key inclusion criteria (4 listed)
- Patients 0-18 yars old.
- Patients requiring intubation with a cuffed specialized endotracheal tube or bronchial blocker.
- Patients having thoracic surgery.
- Patients that require one-lung ventilation (OLV).
Key exclusion criteria (3 listed)
- Patients that do not require to have cuffed specialized endotracheal tube or bronchial blocker.
- Patients not requiring one-lung ventilation.
- Patients not having thoracic surgery.
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 |
|---|---|---|
| Intracuff pressure measurement in one-lung ventilation during thoracic surgery | Procedure or surgery | Intracuff pressure during one-lung ventilation |
Primary outcome
Intracuff pressure during OLV
Time frame: intraoperative
Evaluate changes in intracuff pressure with OLV during thoracic surgery.
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 18 Jan 2019.
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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.
Joseph Tobias principal investigator
Nationwide Children's Hospital
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 One-lung Ventilation (OLV), 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 4 inclusion and 3 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 18 Jan 2019. 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 during OLV (time frame: intraoperative). 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 18 Jan 2019.