Effect of Two Different Surgical Positions on Pulmonary F... | NCT06402474

Studies
Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies

NCT06402474

Sponsor

Istinye University

Status

Unknown status

Last Update Posted

May 7, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Pulmonary Pathology

Interventions

sunbed position

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Jun 5, 2024Estimated

Completion Date

Jul 15, 2024Estimated

First Submitted Date

May 1, 2024

First Submission Date that Met QC Criteria

May 3, 2024

First Posted Date

May 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2024

Last Update Posted Date

May 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary purpose of the study is to investigate the effect of the 30° reverse trendelenburg position combined with the sunbed position on respiratory parameters in laparoscopic gastrectomies.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sunbed position		30° reverse trendelenburg legs together 30° hip flexion (sunbed position)	Procedure: sunbed position
control		30° reverse trendelenburg	Procedure: sunbed position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sunbed position	Procedure	30° reverse trendelenburg legs together 30° hip flexion (sunbed position)	control sunbed position

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
inspiratory pressure	effect on inspiratory pressure of two different position	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who can tolerate general anesthesia and pneumoperitoneum.
Patients who can give informed consent for surgery.
Patients over 18 years of age
patients with body mass index (BMI) > 30 kg/m2
Patients with American Society of Anesthesiologists (ASA) physical status I and II

Exclusion Criteria:

Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
patients with a history of cerebrovascular disease such as intracranial hypertension, cerebral infarction, cerebral hemorrhage, carotid artery stenosis or cerebral ischemia;
Patients with a history of chronic lung diseases such as chronic obstructive pulmonary disease, asthma, pulmonary bullae or respiratory failure;
Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
Surgeries lasting longer than 90 minutes
Patients with ASA class IV
patients with psychiatric disorders
pregnant or breastfeeding patients
patients with a history of seizures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients aged 18-65 who underwent laparoscopic sleeve gastrectomy

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Istinye Üniversity		Istanbul	Merkez Mahallesi	34250	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10926070	Background	Casati A, Comotti L, Tommasino C, Leggieri C, Bignami E, Tarantino F, Torri G. Effects of pneumoperitoneum and reverse Trendelenburg position on cardiopulmonary function in morbidly obese patients receiving laparoscopic gastric banding. Eur J Anaesthesiol. 2000 May;17(5):300-5. doi: 10.1046/j.1365-2346.2000.00662.x.
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