Otolaryngological SurgeryNCT02376179
Endotracheal Tube Intracuff Pressure and Leak
An observational study of Otolaryngological Surgery, run by Kris Jatana at 1 site in United States.
Trial summary
We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Otolaryngological Surgery
- What is being tested?
- Cuffed ETT
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 1 Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
Who may be able to join
- Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
Who cannot join
- Patient who is intubated with an uncuffed endotracheal tube.
- Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy
We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.
- Conditions
- Otolaryngological Surgery
- Being tested
- Cuffed ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed ETTDevice
Also called Kimberly Clark Microcuff ETT
| Study group | Role | What they receive |
|---|---|---|
| Cuffed ETT | Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. Receives: Device: Cuffed ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Intracuff Pressure
Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
Measured: during time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startAug 2014
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otolaryngological 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kris Jatana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kris Jatana, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376179
- Sponsor's protocol ID
- IRB13-00613
- Status last verified
- Dec 2019
- First submitted
- 24 Feb 2015
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9.
PubMed 26956620
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy
- ClinicalTrials.gov ID
- NCT02376179
- Acronym / sponsor ID
- IRB13-00613
- Conditions
- Otolaryngological Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kris JatanaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cuffed ETT | – | Device: Cuffed ETTPediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
Key inclusion criteria (1 listed)
- Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
Key exclusion criteria (2 listed)
- Patient who is intubated with an uncuffed endotracheal tube.
- Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.
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 ETTAlso: Kimberly Clark Microcuff ETT | Device | Cuffed ETT |
Primary outcome
Changes in the Intracuff Pressure
Time frame: during time of surgery
Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26956620Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9.
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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 Otolaryngological Surgery, run by Kris Jatana 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 2 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 11 Dec 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?
Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in the Intracuff Pressure (time frame: during time of surgery). 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 NCT02376179, 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 11 Dec 2019.