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Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery (PCV-VG)

Primary Purpose

Atelectasis, Atelectases, Postoperative Pulmonary

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

VCV

PCV-VG

lung ultrasonography

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring postoperative atelectasis, mechanical ventilation, laparoscopic surgery, lung ultrasonography, volume controlled ventilation, pressure controlled

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

undergoing laparoscopic surgery
ASA Status I-II

Exclusion Criteria:

Gastroesophageal reflux
obstructive sleep apnea syndrome
BMI>30
severe lung and heart disease
ASA Status III-IV

Sites / Locations

Marmara University School of Medicine
Derince Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

VCV-Lung Ultrasonography

PCV-VG- Lung Ultrasonography

Arm Description

patients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography. after induction of anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode.

patients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography.after induction of anesthesia patients will be supported by mechanical ventilation on pressure controlled volume guaranteed mode

Outcomes

Primary Outcome Measures

Effect of different ventilation mods on development of peroperative atelectasis

Patients undergoing laparoscopic surgery will be assigned either volume controlled mode or pressure support volume guaranteed mode. After the operation a researcher will perform lung ultrasonography postoperative at minute 5. Researcher will detect 6 region of each lung totally 12 regions . The researcher will record the modified and original lung ultrasonography scores (LUS Score) of the patients. LUS Score is a scoring system to evaluate atelectasis of lung and scores 1-3 points for each region (Min score 0 max score 36)

Secondary Outcome Measures

Effect of different ventilation mods on development of peroperative atelectasis

Patients undergoing laparoscopic surgery will be assigned either volume controlled mode or pressure support volume guaranteed mode. After the operation a researcher will perform lung ultrasonography in postoperative care unit at minute 30. Researcher will detect 6 region of each lung totally 12 regions . The researcher will record the modified and original lung ultrasonography scores (LUS Score) of the patients. LUS Score is a scoring system to evaluate atelectasis of lung and scores 1-3 points for each region.(Min score 0 max score 36)

Full Information

NCT ID

NCT03614845

First Posted

July 22, 2018

Last Updated

November 25, 2019

Sponsor

Derince Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03614845

Brief Title

Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery

Acronym

PCV-VG

Official Title

Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

September 15, 2019 (Actual)

Study Completion Date

September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Derince Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

In this study researchers aim to evaluate effect of different ventilation modalities on the developments of atelectasis by using ultrasound.

Detailed Description

Patients undergoing laparoscopic surgery will be randomly assigned either volume controlled ventilation group or pressure controlled volume guaranteed ventilation group. All patients will be performed lung ultrasonography pre and postoperatively to evaluate the development of lung atelectasis and effect of different ventilation modalities on the development of atelectasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atelectasis, Atelectases, Postoperative Pulmonary

Keywords

postoperative atelectasis, mechanical ventilation, laparoscopic surgery, lung ultrasonography, volume controlled ventilation, pressure controlled

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VCV-Lung Ultrasonography

Arm Type

Active Comparator

Arm Description

Arm Title

PCV-VG- Lung Ultrasonography

Arm Type

Active Comparator

Arm Description

patients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography.after induction of anesthesia patients will be supported by mechanical ventilation on pressure controlled volume guaranteed mode

Intervention Type

Procedure

Intervention Name(s)

VCV

Intervention Description

after induction for anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode

Intervention Type

Procedure

Intervention Name(s)

PCV-VG

Intervention Description

after induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode

Intervention Type

Diagnostic Test

Intervention Name(s)

lung ultrasonography

Intervention Description

all patients will be performed lung ultrasonography pre and postoperatively

Primary Outcome Measure Information:

Title

Effect of different ventilation mods on development of peroperative atelectasis

Description

Time Frame

at minute 5 in postoperative care unit

Secondary Outcome Measure Information:

Title

Effect of different ventilation mods on development of peroperative atelectasis

Description

Patients undergoing laparoscopic surgery will be assigned either volume controlled mode or pressure support volume guaranteed mode. After the operation a researcher will perform lung ultrasonography in postoperative care unit at minute 30. Researcher will detect 6 region of each lung totally 12 regions . The researcher will record the modified and original lung ultrasonography scores (LUS Score) of the patients. LUS Score is a scoring system to evaluate atelectasis of lung and scores 1-3 points for each region.(Min score 0 max score 36)

Time Frame

at minute 30 in postoperative care unit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: undergoing laparoscopic surgery ASA Status I-II Exclusion Criteria: Gastroesophageal reflux obstructive sleep apnea syndrome BMI>30 severe lung and heart disease ASA Status III-IV

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayten Saracoglu

Organizational Affiliation

Marmara Unıversity Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Marmara University School of Medicine

City

Istanbul

Country

Turkey

Facility Name

Derince Research and Training Hospital

City

Kocaeli

ZIP/Postal Code

41900

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery

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