Effect of PCV and VCV on Extravascular Lung Water

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03514706

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) are the common ventilatory modes during OLV undergoing thoracic surgery. A controversy regarding which ventilation mode is better for oxygenation during OLV with PCV enhances oxygenation more than VCV ;given its initial high peak inspiratory flow rates and its rapidly decelerating flow pattern. However, this high peak inspiratory flow rate might also provoke lung injury via shearing and traction forces on the alveoli. Extravascular lung water describes water within the lungs but outside pulmonary vasculature. Lung ultrasound (LUS) assessment of EVLW by B-lines provides a reliable and easy alternative.

Condition or Disease	Intervention/Treatment	Phase
Extravascular Lung Water	Diagnostic Test: volume controlled ventilation Diagnostic Test: pressure controlled ventilation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Adult patients scheduled for elective thoracic surgery with one lung ventilation will be included in the study. Patients will be randomly allocated into one of two groups: Group V: will receive volume controlled mechanical ventilation. Group P: will receive pressure controlled mechanical ventilation.Adult patients scheduled for elective thoracic surgery with one lung ventilation will be included in the study. Patients will be randomly allocated into one of two groups:Group V: will receive volume controlled mechanical ventilation. Group P: will receive pressure controlled mechanical ventilation.

Masking:

Single (Investigator)

Masking Description:

Lung ultrasound will be done by an investigator blinded to group allocation

Primary Purpose:

Screening

Official Title:

The Ultrasound Estimation of Extravascular Lung Water in Volume Controlled Versus Pressure Controlled Ventilation After One Lung Ventilation in Thoracoscopic Surgery. A Comparative Study

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Volume controlled ventilation Group V: Patients will receive volume controlled mechanical ventilation. (Vt 7ml/kg ideal body weight).	Diagnostic Test: volume controlled ventilation Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines. The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36 Other Names: LUS
Experimental: Pressure controlled ventilation Group P: Patients will receive pressure controlled mechanical ventilation. (to achieve Vt 7 ml/kg ideal body weight, Pmax 30 cmH2O)	Diagnostic Test: pressure controlled ventilation Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines. The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36 Other Names: LUS

Arm

Intervention/Treatment

Experimental: Volume controlled ventilation

Group V: Patients will receive volume controlled mechanical ventilation. (Vt 7ml/kg ideal body weight).

Diagnostic Test: volume controlled ventilation

Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines. The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36

Other Names:

LUS

Experimental: Pressure controlled ventilation

Group P: Patients will receive pressure controlled mechanical ventilation. (to achieve Vt 7 ml/kg ideal body weight, Pmax 30 cmH2O)

Diagnostic Test: pressure controlled ventilation

Other Names:

LUS

Outcome Measures

Primary Outcome Measures

Lung ultrasound score [change of lung ultrasound scores introperatively during double lung and single lung ventilation and after 2 hours postoperatively compared to baseline scores before anesthesia induction]
The sum of B lines reflects the extent of lung water accumulation. The lung ultrasound score(LUS) will be obtained by scanning 12-rib interspaces. The dependent lung will be divided into six areas: two anterior areas, two lateral areas, and two posterior areas. The anterior chest wall (zone 1) will be delineated from the parasternal to the anterior axillary line and will be divided into upper and lower halves, from the clavicle to the third intercostal space and from the third to the diaphragm. The lateral area (zone 2) will be delineated from the anterior to the posterior axillary line and was divided into upper and basal halves. The posterior area (zone 3) will be considered as the zone beyond the posterior axillary line. The sum of B-lines on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score from 0 to 36(10) score for the ventilated lung is only from 0-18.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients aged (18-60 years), undergoing elective thoracoscopic surgery with one lung ventilation

Exclusion Criteria:

Emergency surgeries.
Left Ventricular ejection fraction less than 40%.
Any patient known to have pulmonary hypertension
Patients with preoperative congestive heart failure, cardiogenic shock, preoperative pulmonary edema
Hepatic patients (liver functions double the upper reference range)
Morbid obesity (BMI > 40).
Renally impaired patients with creatinine more than 2 mg/dl.
Any patient with respiratory dysfunction (FEV1<60% of the expected).
Any patient with previous thoracic surgery.
One lung ventilation more than 2 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Al-Ainy faculty of medicine. Cairo University	Cairo		Egypt	11516

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Hisham Hosny, MD, Kasr Al-Ainy Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hisham Hosny, Associate professor, Cairo University

ClinicalTrials.gov Identifier:

NCT03514706

Other Study ID Numbers:

AnesthN-8-2018

First Posted:

May 2, 2018

Last Update Posted:

Mar 5, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hisham Hosny, Associate professor, Cairo University

Extravascular lung water

one lung ventilation

volume controlled ventilation

pressure controlled ventilation

Study Results

No Results Posted as of Mar 5, 2019