Effect of PCV and VCV on Extravascular Lung Water

March 4, 2019 updated by: Hisham Hosny, Cairo University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

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

      • Cairo, Egypt, 11516
        • Kasr Al-Ainy faculty of medicine. Cairo University

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volume controlled ventilation
Group V: Patients will receive volume controlled mechanical ventilation. (Vt 7ml/kg ideal body weight).

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)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound score
Time Frame: 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.
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

Collaborators and Investigators

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

Investigators

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

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)

March 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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