Anesthesia Intubation ComplicationNCT01885793
Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup
An observational study of Anesthesia Intubation Complication, run by Senthil G. Krishna at 1 site in United States.
Trial summary
This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Cuffed endotracheal tube
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical patients that require endotracheal intubation.
Who may be able to join
- Intubation of trachea with a cuffed endotracheal tube.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- Cuffed endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed endotracheal tubeDevice
Intubation with a cuffed endotracheal tube (ETT).
| Study group | Role | What they receive |
|---|---|---|
| Cuffed endotracheal tube | Surgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT). Receives: Device: Cuffed endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff pressure
Intracuff pressure is measured via handheld manometer and by using the transducer of an invasive pressure monitoring device.
Measured: Immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senthil G. Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senthil G. Krishna, Nationwide Children's Hospital
- Investigators
- Senthil Gopalakrishnan, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885793
- Sponsor's protocol ID
- IRB13-00107
- Status last verified
- Jan 2017
- First submitted
- 18 Jun 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup
- ClinicalTrials.gov ID
- NCT01885793
- Acronym / sponsor ID
- IRB13-00107
- Conditions
- Anesthesia Intubation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Senthil G. KrishnaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jun 2013 (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.
This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cuffed endotracheal tube | – | Device: Cuffed endotracheal tubeSurgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical patients that require endotracheal intubation.
Key inclusion criteria (1 listed)
- Intubation of trachea with a cuffed endotracheal tube.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cuffed endotracheal tubeIntubation with a cuffed endotracheal tube (ETT). | Device | Cuffed endotracheal tube |
Primary outcome
Intracuff pressure
Time frame: Immediately after intubation
Intracuff pressure is measured via handheld manometer and by using the transducer of an invasive pressure monitoring device.
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 31 Jan 2017.
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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.
Senthil Gopalakrishnan, MD 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 Anesthesia Intubation Complication, run by Senthil G. Krishna 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 31 Jan 2017. 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 after intubation). 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 31 Jan 2017.