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

• Sponsor: Derince Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03614845
• Collaborator: (none)
• Enrollment: 62
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site: 31
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atelectasis; Atelectases, Postoperative Pulmonary	Procedure: VCV; Procedure: PCV-VG; Diagnostic Test: lung ultrasonography	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Clinical Trial
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Sep 15, 2019
• Actual Study Completion Date: Sep 15, 2019

Arms and Interventions

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	Procedure: PCV-VG; after induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode; Diagnostic Test: lung ultrasonography; all patients will be performed lung ultrasonography pre and postoperatively

Outcome Measures

Primary Outcome Measures

1. Effect of different ventilation mods on development of peroperative atelectasis [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)

Secondary Outcome Measures

1. Effect of different ventilation mods on development of peroperative atelectasis [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University School of Medicine	Istanbul		Turkey
2	Derince Research and Training Hospital	Kocaeli		Turkey	41900

Sponsors and Collaborators

• Derince Training and Research Hospital

Investigators

• Study Director: Ayten Saracoglu, Marmara Unıversity Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ayse Zeynep Turan, Principal Investigator, Derince Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03614845
• Other Study ID Numbers: DerinceTRH-006
• First Posted: Aug 3, 2018
• Last Update Posted: Nov 26, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ayse Zeynep Turan, Principal Investigator, Derince Training and Research Hospital: postoperative atelectasis; mechanical ventilation; laparoscopic surgery; lung ultrasonography; volume controlled ventilation; pressure controlled
• Additional relevant MeSH terms: Pulmonary Atelectasis

Study Results

No Results Posted as of Nov 26, 2019