Otolaryngological SurgeryNCT02640248
Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy
An observational study of Otolaryngological Surgery, run by Kris Jatana at 1 site in United States.
Trial summary
The investigators have devised a simple method to continuously measure the 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?
- Cuff ETT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2020
- 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: 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
The investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators 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 and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.
- Conditions
- Otolaryngological Surgery
- Being tested
- Cuff ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuff ETTDevice
| Study group | Role | What they receive |
|---|---|---|
| Cuff ETT | Not described Receives: Device: Cuff ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intracuff pressure
Changes in intracuff pressure of cuffed ETT related to the position 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 posted28 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Original PI left NCH, study never started then
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT02640248
- Sponsor's protocol ID
- IRB15-00902
- Status last verified
- Nov 2019
- First submitted
- 22 Dec 2015
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. 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 Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT02640248
- Acronym / sponsor ID
- IRB15-00902
- Conditions
- Otolaryngological Surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Original PI left NCH, study never started then
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kris JatanaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Dec 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 investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators 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 and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cuff ETT | – | Device: Cuff ETT |
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 |
|---|---|---|
| Cuff ETT | Device | Cuff ETT |
Primary outcome
Changes in intracuff pressure
Time frame: during time of surgery
Changes in intracuff pressure of cuffed ETT related to the position of the patient's head and retractor placement.
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 22 Oct 2021.
Related trials for Otolaryngological Surgery
Recruiting
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
Otolaryngological Disease, Obstructive Sleep Apnea
Not yet recruiting
Remifentanil Monotherapy vs. Remifentanil-Nicardipine for Controlled Hypotension in Otolaryngological Surgery
Otolaryngological Surgery, Anesthesia
RecruitingObservational study
AI Recognition of Important Structures in Otolaryngological Surgery
Otolaryngological Diseases Requiring Mastoidectomy, Middle Ear Surgery, Endolymphatic Sac Surgery, Cochlear Implant, Labyrinthectomy, Petrous Apex Lesions, Facial Nerve Surgery, and Lateral Skull Base Tumors
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: withdrawn, as of the sponsor's last update on 22 Oct 2021. 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?
Changes in 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?
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 22 Oct 2021.