Effects of Recruitment Manouever on Oxygenation, Oxygen Reserve Index and Postoperative Pulmonary Complications

NCT ID: NCT05705245

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-22

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Patients with body mass index\> 40 m2, scheduled for bariatric surgery under general anesthesia will be monitorised with the ORi sensor and monitored at regular intervals. Preoperative and postoperative lung aeration will be evaluated with lung ultrasaund. İntraoperative standart anesthesia will be administered by an anesthesiolıgist not aware of the ultrasound. Alveolar recruitment will be applied by the same anesthesiologist if necessary. Blood gas samples obtained throughout surgery will be evaluated. ORİ values and intraoperative vital, respiratory, neuromuscular monitoring parameters will be obtained. Postoperative pulmonary complicationsa will be evaluated at postoperative day 5.

Finding will be compared between patients who received recruitment and who did not.

Conditions

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Obesity Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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recruitment

Patients who received alveolar recruitment manouever during bariatric surgery

recruitment

Intervention Type OTHER

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

non recruitment

patients who did not receive alveolar recruitment manoeuver during bariatric surgery

No interventions assigned to this group

Interventions

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recruitment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balikesir University

OTHER

Sponsor Role lead

Responsible Party

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hafize fisun demir

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Balikesir University Hospital

Balıkesir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hafize Fisun Demir

Role: CONTACT

05437838615

Nazan Kocaoğlu

Role: CONTACT

0 5326664869

Facility Contacts

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Hafize Fi Demir

Role: primary

09005437838615

Nazan Kocaoğlu

Role: backup

090 0 5326664869

Other Identifiers

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2021/138

Identifier Type: -

Identifier Source: org_study_id

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