Effects of Recruitment Maneuver on Functional Residual Capacity

Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia; Atelectasis
• Intervention / Treatment: Procedure: recruitment maneuver

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Department of anesthesiology
  • Istanbul, Turkey, 34069
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery

Exclusion Criteria:

1. <18 years old
2. >65 years old
3. denial of patient
4. patients having one of: lung disease, cardiac failure, severe cardiac valvular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; 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.
Experimental: study group; 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	Procedure: recruitment maneuver; 30 cmH2O pressure 15 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within max 5 minutes after the intubation and with max 5 minutes before the extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	in recovery room 30 minutes after operation

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Elif Aygun, MD, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 2018/938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No