NCT05705245

Brief Summary

General anesthesia and mechanical ventilation decrease pulmonar volume; attenuate small airway closure, atelectasis, and increase the rate of hypoxia and postoperative pulmonary complications. Lung volume in obese patients decreases inversely with the increase in body mass index. Obesity is associated with increased atelectasis, hypoxia and postoperative pulmonary complication rates during anesthesia . Alveolar recruitment maneuver is a technique where high positive end-expiratory pressure (PEEP) is applied for for short periods, follwed by a continuous PEEP appşication throughout surgery. This has become a standard practice during anesthesia in recent years. Oxygen reserve index (ORi) is an index measured with a non-invasive finger-tip sensor and shows the oxygen content of the venous blood. It is effective at high oxygen levels and may indicate the presence of hyperoxia. Our aim is to examine the effect of alveolar recruitment maneuver on oxygenation parameters under anesthesia and the correlation with ORi in morbidly obese patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 20, 2023

Last Update Submit

January 27, 2023

Conditions

Keywords

obesity, bariatric surgery, alveolar recruitment, oxygen reserve index

Outcome Measures

Primary Outcomes (1)

  • postoperative pulmonary complications

    Coughing, dyspnoe, side pain, phlegm

    5 days

Secondary Outcomes (1)

  • Effect of recruitment manoeuver on oxygene reserve index

    intraoperative

Study Arms (2)

recruitment

Patients who received alveolar recruitment manouever during bariatric surgery

Other: recruitment

non recruitment

patients who did not receive alveolar recruitment manoeuver during bariatric surgery

Interventions

Automated alveolar recruitment menouever applied during mechanical ventilation in the intraoperative period

recruitment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

obese patients with BMI\> 40 scheduşed for bariatric surgery

You may qualify if:

  • Bariatric surgery general anesthesia and mechanical ventilation via orotracheal entubation Age between 18-65 ASA I-III BMI \> 40 m-2

You may not qualify if:

  • Previous history of thorasic surgery, pneumothorax Chemo or Radiotherapy to the chest within 2 months History of Respiratory disease (COPD, emphysema, pneumonia, lung malignancy, Lung Bulla ) Emergency surgery Cardiovascular, renal, hepatic, neuromuscular disease İntracrabial pathology or trauma High intraoptic pressure Pulmonary Hypertension Pregnancy Criticall illness, or history of mechanical ventilation within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University Hospital

Balıkesir, 10145, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hafize Fisun Demir

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 30, 2023

Study Start

January 22, 2022

Primary Completion

January 1, 2024

Study Completion

July 1, 2024

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

no plan to sharing

Locations