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

November 25, 2019 updated by: Ayse Zeynep Turan, Derince Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University School of Medicine
      • Kocaeli, Turkey, 41900
        • Derince Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VCV-Lung Ultrasonography
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.
Procedure: VCV
after induction for anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode
Diagnostic test: lung ultrasonography
all patients will be performed lung ultrasonography pre and postoperatively
Active Comparator: PCV-VG- Lung Ultrasonography
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
Diagnostic test: lung ultrasonography
all patients will be performed lung ultrasonography pre and postoperatively
Procedure: PCV-VG
after induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of different ventilation mods on development of peroperative atelectasis
Time Frame: at minute 5 in postoperative care unit
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)
at minute 5 in postoperative care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of different ventilation mods on development of peroperative atelectasis
Time Frame: at minute 30 in postoperative care unit
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)
at minute 30 in postoperative care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Investigators

  • Study Director: Ayten Saracoglu, Marmara Unıversity Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

September 15, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

July 22, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DerinceTRH-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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