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RecruitingNCT06738875Updated Dec 18, 2024

Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery

An observational study in Bariatric Surgery, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
18 Years to 70 Years
Sex
All
01

Study 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. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.

02

Conditions studied

  • Bariatric Surgery
03

In context

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

28

Inclusion criteria

  • American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70

Exclusion criteria

Exclusion Criteria:

  • Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Devicemanometre

    Increases in peak and mean airway pressures of ETT cuff pressures will be monitored in patients undergoing laparoscopic bariatric surgery

06

What researchers measure

Primary outcomes

  1. ETT cuff pressure

    ETT cuff pressure

    Time frame: 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

    Time frame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation

07

Study locations

1 of 1 sites recruiting
  • Health Sciences University Gazi Yaşargil Training and Research Hospital
    Kayapinar, Di̇yarbakir, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06738875
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible party
Hülya Tosun Söner (Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Principal investigator
First posted
Dec 18, 2024
Start date
Dec 10, 2024
Primary completion
Jan 10, 2025 (estimated)
Completion
Jan 15, 2025 (estimated)
Last update
Dec 18, 2024

Study contacts

Hülya Tosun Söner, doktor
Contact
hulyatosunsoner@hotmail.com
+905352792102

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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