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

NCT03614845 | Completed

• 1 other identifier: DerinceTRH-006
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atelectasis; Atelectases, Postoperative Pulmonary

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  at minute 5 in postoperative care unit

Secondary Outcomes (1)

• Effect of different ventilation mods on development of peroperative atelectasis

  at minute 30 in postoperative care unit

Study Arms (2)

VCV-Lung Ultrasonography

ACTIVE COMPARATOR

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; Diagnostic Test: lung ultrasonography

PCV-VG- Lung Ultrasonography

ACTIVE COMPARATOR

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; Diagnostic Test: lung ultrasonography

Interventions

VCV PROCEDURE

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

VCV-Lung Ultrasonography

PCV-VG PROCEDURE

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

PCV-VG- Lung Ultrasonography

lung ultrasonography DIAGNOSTIC_TEST

all patients will be performed lung ultrasonography pre and postoperatively

PCV-VG- Lung Ultrasonography; VCV-Lung Ultrasonography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing laparoscopic surgery
• ASA Status I-II

You may not qualify if:

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

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (2)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ayten Saracoglu

  Marmara Unıversity Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2018
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

TU (2)