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Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery

Primary Purpose

Bariatric Surgery, Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lung Recruitment Conventional
Lung Recruitment Ultrasound
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bariatric Surgery focused on measuring Morbidly obese, Bariatric surgery, Lung recruitment

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult morbidly obese patients of BMI more than 40, scheduled for laparoscopic bariatric surgery Exclusion Criteria: Patient refusal Patients with history of severe obstructive or restrictive pulmonary disease. Patients with severe obstructive sleep apnea (OSA). Presence of emphysematous lung bullae. Decompensated cardiac disease (NYHA class 3 or 4). Patients with uncontrolled hepatic or renal disorders.

Sites / Locations

  • Tanta UniversityRecruiting
  • Tanta University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional group (group C)

Ultrasound-guided group (group US)

Arm Description

Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.

Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.

Outcomes

Primary Outcome Measures

the change of Lung Ultrasound Score
Assessment of the changes in the lung ultrasound score

Secondary Outcome Measures

The incidence of atelectasis
defined as LUS of ≥ 2 for any of the 12 regions
The incidence of intra-operative desaturation
defined as an SpO2 <95%

Full Information

First Posted
August 11, 2023
Last Updated
August 18, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06000969
Brief Title
Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery
Official Title
Conventional Versus Ultrasound-guided Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery: Prospective Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 13, 2024 (Anticipated)
Study Completion Date
August 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative technique that has been widely used in clinical monitoring and diagnosis. Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the effects of lung recruitment manoeuvres. This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of intraoperative& postoperative oxygen desaturation, and reduce the incidence of post operative pulmonary complications. The aim of this prospective randomized clinical study is to compare the conventional recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients scheduled for laparoscopic bariatric surgery.
Detailed Description
This prospective randomized clinical double-blinded study will be carried out at Anesthesiology Department in Tanta University Hospitals for one year from August 2023 to August 2024 after approval from our institutional ethical committee. All enrolled patients will sign an informed written consent to participate in the study. Every patient will receive an explanation of the purpose of the study and have secret code number to ensure privacy and confidentiality, all given data will be used for scientific purposes only. Any unexpected risks encountered during the research will be cleared to the participants, as well as to the Ethical Committee on time. The risk at the study includes increased risk of bradycardia and hypotension that will be managed by adequate monitoring, atropine, IV fluids, and ephedrine. -Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :- • Conventional group (group C); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds. • Ultrasound-guided group (group US); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed. -Anesthesia technique I-Preoperative assessment: ▪ All patients will be assessed preoperatively at the Anesthesia Clinic through history, physical examination and requesting the appropriate investigations. II-In the Holding Area: Patient counselling regarding anesthesia technique and surgery. Secured IV line. III- In the Operation Room: Standard Monitoring: On arrival of the patient to the operating theater and before induction of anesthesia, all standard monitors will be applied, including heart rate (HR), ECG, oxygen saturation (SpO2), end-tidal CO2, non-invasive blood pressure, and temperature. Induction of anesthesia: all patients will be pre-oxygenated with 80% oxygen for 3 minutes before induction. Anesthesia will be induced by slowly titrating doses of intravenous fentanyl (2 ug/kg of lean body weight) and propofol (1 mg/kg of lean body weight). Intubation will be facilitated with atracurium (0.5 mg/kg of lean body weight). Anesthesia will be maintained with atracurium, isoflurane of 1 MAC and fraction inspired Oxygen of 0.5 for each patient. Mechanical ventilation protocol: patients will receive the standard ventilation protocol as follows: volume-controlled ventilation mode, with a tidal volume of 4-6 mL/kg of predicted body weight, inspiratory: expiratory ratio 1: 2, PEEP 5 cmH2O, initial respiratory rate is 12/m then adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35- and 40-mm Hg, and inspired oxygen fraction of 0.5 with total gas flow 1L/m. The patients and investigators who will be responsible for assessing the primary outcomes will be blinded to study group assignment. However, the attending anesthesiologists, intraoperative nursing staff, and intraoperative assessors will not be blinded to study group assignment. Positioning and pneumoperitoneum: the patients will be put in reverse trendelenburg position, 30°C head-up position slowly, the position will be kept until the end of surgery. Intraabdominal pressure will be maintained between 12 ± 3 cmH2O during surgery. ▪ Lung ultrasound examination: will be done: After the induction of anaesthesia (time point T1). After pneumoperitoneum (time point T2). At the end of surgery (before administrating reversal agents for neuromuscular blockade; (time point T3). Lung recruitment: recruitment maneuver will be performed in each group as described before after every intraoperative lung ultrasound examination. Intra-abdominal pressure will be recorded. If hypotension (MAP<65mmhg), bradycardia (heart rate<50/m.) or oxygen desaturation (spO2<95%) has been occurred, rescue strategy will be applied as described later. Rescue strategy for oxygen desaturation: In both groups, when SpO2 decreased to 95% or lower, the following rescue ventilation strategies will be performed in a stepwise manner (i.e., if SpO2 did not increase after a step, then the following step was applied; otherwise, no further steps were applied). Steps were performed according to the following order: Step (1), three rounds of recruitment maneuvers with a pressure of 30 cmH2O for 10 s. Step (2), three rounds of recruitment maneuvers with a pressure of 35 cmH2O for 10 s. Step (3), increase FIO2 to 1.0. If SpO2 did not increase after all three rescue strategies, the ventilation strategies could be modified according to the attending anesthesiologist's judgement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Obesity, Morbid
Keywords
Morbidly obese, Bariatric surgery, Lung recruitment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :- Conventional group (group C); 30 patients: Ultrasound-guided group (group US); 30 patients:
Masking
ParticipantOutcomes Assessor
Masking Description
The participants will be kept blind through the use of ultrasound assessment in both groups. Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional group (group C)
Arm Type
Experimental
Arm Description
Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
Arm Title
Ultrasound-guided group (group US)
Arm Type
Experimental
Arm Description
Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
Intervention Type
Device
Intervention Name(s)
Lung Recruitment Conventional
Intervention Description
the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
Intervention Type
Device
Intervention Name(s)
Lung Recruitment Ultrasound
Intervention Description
the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
Primary Outcome Measure Information:
Title
the change of Lung Ultrasound Score
Description
Assessment of the changes in the lung ultrasound score
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
The incidence of atelectasis
Description
defined as LUS of ≥ 2 for any of the 12 regions
Time Frame
2 hours
Title
The incidence of intra-operative desaturation
Description
defined as an SpO2 <95%
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult morbidly obese patients of BMI more than 40, scheduled for laparoscopic bariatric surgery Exclusion Criteria: Patient refusal Patients with history of severe obstructive or restrictive pulmonary disease. Patients with severe obstructive sleep apnea (OSA). Presence of emphysematous lung bullae. Decompensated cardiac disease (NYHA class 3 or 4). Patients with uncontrolled hepatic or renal disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohair Soliman, Professor
Phone
00201283929049
Email
sohairsoliman@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Aly, Professor
Phone
00201099957971
Email
moh_aly_2005@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Ismaiel, M.D
Organizational Affiliation
Assistant Professor of Anesthesia and Intensive Care, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalik, M.D
Phone
+201002977048
Email
samehabdelkhalik1982@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Aly, M.D
Phone
00201099957971
Email
moh_aly_2005@hotmail.com
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohair Soliman, Professor
Phone
00201283929049
Email
sohairsoliman@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Abduallah, M.D
Phone
00201099957971
Email
moh_aly_2005@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD will be available with the principle investigator within 6 months after publishing the study.
IPD Sharing Time Frame
within 6 months after publishing the study.
IPD Sharing Access Criteria
Contact samehabdelkhalik1982@gmail.com

Learn more about this trial

Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery

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