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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03614845
Other study ID # DerinceTRH-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date September 15, 2019

Study information

Verified date November 2019
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date September 15, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Marmara University School of Medicine Istanbul
Turkey Derince Research and Training Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) at minute 30 in postoperative care unit
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