Bariatric SurgeryNCT06738875
Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery
An observational study of Bariatric Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- manometre
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 15 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 28
Who may be able to join
- American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70
Who cannot join
- Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University Gazi Yaşargil Training and Research Hospital
Kayapınar, Di̇yarbakir
hulyatosunsoner@hotmail.com
About this study
This prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.
- Conditions
- Bariatric Surgery
- Being tested
- manometre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manometreDevice
Increases in peak and mean airway pressures of ETT cuff pressures will be monitored in patients undergoing laparoscopic bariatric surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ETT cuff pressure
ETT cuff pressure
Measured: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
Secondary outcomes (1)
Peak airway pressures
Peak airway pressures
Measured: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Dec 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738875
- Sponsor's protocol ID
- HTONER
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06738875
- Acronym / sponsor ID
- HTONER
- Conditions
- Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- 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 prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 28
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70
Key exclusion criteria (1 listed)
- Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.
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 |
|---|---|---|
| manometreIncreases in peak and mean airway pressures of ETT cuff pressures will be monitored in patients undergoing laparoscopic bariatric surgery | Device | – |
Primary outcome
ETT cuff pressure
Time frame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
ETT cuff pressure
1 secondary outcome
Peak airway pressures
Time frame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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 Bariatric Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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: looking for participants now, as of the sponsor's last update on 18 Dec 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hülya Tosun Söner, doktor (+905352792102, hulyatosunsoner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETT cuff pressure (time frame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation). 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 Dec 2024.