Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score

Bariatric Surgery Clinical Trial

Official title:

Comparison Between Two Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05720351
• Other study ID #: 35292\2\22
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: January 2023
• Source: Tanta University
• Contact: Alaa M Shahien, MD
• Phone: +201555957744
• Email: alaa162094_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the staircase alveolar recruitment maneuver with PEEP titration versus sustained inflation alveolar recruitment maneuver by using lung ultrasound score as an indicator of improving lung atelectasis in bariatric surgery

Description:

Weight loss surgery, often known as bariatric surgery, is an effective obesity treatment. Most people undergoing such surgery may show an improvement in, or the resolution of, conditions such as diabetes, dyslipidemia, hypertension, and obstructive sleep apnea.

Currently, there is no standard ventilation strategy has been established for obese patients. However, there is some evidence that recruitment maneuvers (RM) combined with protective lung ventilation strategy improve oxygenation and compliance compared to other strategies.

Alveolar recruitment maneuver refers to the periodic hyperinflation of the lungs that has been utilized to open up the lung and keep the lung open in anesthetized patients. The use of recruitment maneuvers has been shown to reduce the incidence and extent of atelectasis during general anesthesia by different methods.

Lung ultrasonography is considered a useful tool in perioperative care. Recent research showed that lung ultrasound could assess lung aeration and diagnose anesthesia-induced atelectasis accurately in the perioperative period by measuring the extent of atelectasis by the scoring system; also, the response to recruitment manoeuver for each patient can be evaluated easily. Thus, it has great potential as a bedside non-invasive, sensitive tool for guiding effective recruitment manoeuvers to reduce the formation of pulmonary atelectasis in the surgical setting

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult morbidly obese patients (Body mass index < 40kg / m2 or Body mass index < 35kg / m2 with obesity-related comorbidities such as hypertension, diabetes, and sleep apnea)

• undergo elective bariatric laparoscopic surgery with an expected duration of at least one hour under general anesthesia.

Exclusion Criteria:

• Patient refusal to participate in the study.

• Patients with a previous history of thoracic surgery.

• Patients with a history of chest disease (COPD, emphysema, or pneumothorax).

• Patients with abnormal pre-operative chest radiographs such as pneumonia, pleural effusion.

• Patients with heart failure or impending failure.

• Patients with known hypovolemia.

• Patients with increased intracranial pressure.

Related Conditions & MeSH terms

• Atelectasis
• Bariatric Surgery
• Pulmonary Atelectasis

Intervention

Procedure:
• Lachmann maneuver
Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)
• Staircase maneuver
Patients undergone Undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point

Locations

Country	Name	City	State
Egypt	Alaa Mohsen Shahien	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Lung ultrasound score.	Access lung ultrasound score at the end of surgery	48 hours postoperatively
Secondary	Access Pulmonary complications	Pulmonary complications were measured as (pneumonia, pulmonary edema, pleural effusion, and pneumothorax).	48 hours postoperatively
Secondary	Access incidence of oxygen desaturation	incidence of oxygen desaturation was measured	48 hours Postoperatively
Secondary	Access Complications of recruitment maneuver	Complications of recruitment maneuver including bradycardia, hypotension were measured	48 hours Postoperatively