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Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients

Primary Purpose

Recruitment, Obesity, Morbid, Laparoscopy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Recruitment maneuver
No recruitment maneuver
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recruitment

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients between the ages of 18 and 65
  2. Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery
  3. ASA (American Society of Anesthesiologists) 2-3 patients

Exclusion Criteria:

  1. Smokers
  2. Patients with previous abdominal surgery
  3. Patients with obstructive / restrictive lung disease,
  4. Patients with coronary artery disease, heart failure
  5. Patients with chronic kidney failure

Sites / Locations

  • Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recruitment maneuver

No recruitment maneuver

Arm Description

Recruitment maneuver

No recruitment maneuver

Outcomes

Primary Outcome Measures

Peak airway pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Plateau airway pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Driver airway pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Static airway compliance
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Dynamic airway compliance
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
End tidal CO2 pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)

Secondary Outcome Measures

Heart rate
This will me measured at 5 different times using electrocardiography and will be reported as beat per minute (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Mean arterial pressure
This will me measured at 5 different times using non invasive blood pressure monitor and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
SpO2
SpO2 will me measured at 5 different times using pulse oximetry and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Creatinine
Creatinine values will be measured at 24th our using blood tests and will be reported as mg/dL
Urine output
This will be measured hourly for the first 24 hours, using urinary catheter and will be reported as ml per hour.

Full Information

First Posted
February 9, 2020
Last Updated
February 12, 2020
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04269226
Brief Title
Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients
Official Title
The Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics and Postoperative Kidney Functions of Obese Patients Undergoing Laparoscopic Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
April 9, 2020 (Anticipated)
Study Completion Date
May 9, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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
This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery. 128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recruitment, Obesity, Morbid, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recruitment maneuver
Arm Type
Experimental
Arm Description
Recruitment maneuver
Arm Title
No recruitment maneuver
Arm Type
Active Comparator
Arm Description
No recruitment maneuver
Intervention Type
Procedure
Intervention Name(s)
Recruitment maneuver
Intervention Description
Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal peep for the patient, and PEEP will be adjusted at this value after recruitment.
Intervention Type
Procedure
Intervention Name(s)
No recruitment maneuver
Intervention Description
Usual ventilation procedures will be applied.
Primary Outcome Measure Information:
Title
Peak airway pressure
Description
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
Plateau airway pressure
Description
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
Driver airway pressure
Description
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
Static airway compliance
Description
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
Dynamic airway compliance
Description
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
End tidal CO2 pressure
Description
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Heart rate
Description
This will me measured at 5 different times using electrocardiography and will be reported as beat per minute (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
Mean arterial pressure
Description
This will me measured at 5 different times using non invasive blood pressure monitor and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
SpO2
Description
SpO2 will me measured at 5 different times using pulse oximetry and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Time Frame
1 week
Title
Creatinine
Description
Creatinine values will be measured at 24th our using blood tests and will be reported as mg/dL
Time Frame
24th hour
Title
Urine output
Description
This will be measured hourly for the first 24 hours, using urinary catheter and will be reported as ml per hour.
Time Frame
24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 18 and 65 Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery ASA (American Society of Anesthesiologists) 2-3 patients Exclusion Criteria: Smokers Patients with previous abdominal surgery Patients with obstructive / restrictive lung disease, Patients with coronary artery disease, heart failure Patients with chronic kidney failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basak Bayrak, MD
Phone
+902124147171
Email
basakbayrak2009@gmail.com
Facility Information:
Facility Name
Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basak Bayrak, MD
Phone
+902124147171
Email
basakbayrak2009@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients

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