Back to resultsEffects of Recruitment Maneuver on Functional Residual Capacity
Primary Purpose
Anesthesia, Surgery, Atelectasis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
recruitment maneuver
Sponsored by
About this trial
This is an interventional screening trial for Anesthesia
Eligibility Criteria
Inclusion Criteria:
1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery
Exclusion Criteria:
- <18 years old
- >65 years old
- denial of patient
- patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
Sites / Locations
- Istanbul University
- Istanbul University, Department of Anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
study group
Arm Description
3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation After the operation,Postoperative Room Air Test (RAT) will be applied.
5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds . First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation
Outcomes
Primary Outcome Measures
Comparison of FRC measurements at beginning and end of anesthesia
First FRC will be measured after ; the last FRC will be measure bedore the extubation
Secondary Outcome Measures
Positive room air test
in recovery room when patient modified aldrete score ≥ 9 patient SPO2 when breathing in room air If patients' spo2 value ≤ 96%, named as room air test positive
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04208737
Brief Title
Effects of Recruitment Maneuver on Functional Residual Capacity
Official Title
Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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
Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units.
The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.
Detailed Description
An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with TIVA.
FRC will be measured in different steps of the operation. In the study group, a recruitment manover will be applied to evaluate its effects on FRC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Surgery, Atelectasis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation
After the operation,Postoperative Room Air Test (RAT) will be applied.
Arm Title
study group
Arm Type
Experimental
Arm Description
5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds .
First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation
First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation
Intervention Type
Procedure
Intervention Name(s)
recruitment maneuver
Intervention Description
30 cmH2O pressure 15 seconds
Primary Outcome Measure Information:
Title
Comparison of FRC measurements at beginning and end of anesthesia
Description
First FRC will be measured after ; the last FRC will be measure bedore the extubation
Time Frame
within max 5 minutes after the intubation and with max 5 minutes before the extubation
Secondary Outcome Measure Information:
Title
Positive room air test
Description
in recovery room when patient modified aldrete score ≥ 9 patient SPO2 when breathing in room air If patients' spo2 value ≤ 96%, named as room air test positive
Time Frame
in recovery room 30 minutes after operation
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:
1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery
Exclusion Criteria:
<18 years old
>65 years old
denial of patient
patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Aygun, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34069
Country
Turkey
Facility Name
Istanbul University, Department of Anesthesiology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Recruitment Maneuver on Functional Residual Capacity
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