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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04208737
Other study ID # 2018/938
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 23, 2019
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
recruitment maneuver
30 cmH2O pressure 15 seconds

Locations

Country Name City State
Turkey Istanbul University Istanbul
Turkey Istanbul University, Department of Anesthesiology Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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