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Effect of PCV and VCV on Extravascular Lung Water

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ClinicalTrials.gov Identifier: NCT03514706
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hisham Hosny, Cairo University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : March 1, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: LUS




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514706


Contacts
Contact: Hisham Hosny, MD. DESA +447490399070 hishamhosny@kasralainy.edu.eg

Locations
Egypt
Kasr Al-Ainy faculty of medicine. Cairo University Recruiting
Cairo, Egypt, 11516
Contact: Ahmed El-Agaty, MD    +201007022284    aelgaty@hotmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Hisham Hosny, MD Kasr Al-Ainy Faculty of Medicine

Responsible Party: Hisham Hosny, Associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT03514706     History of Changes
Other Study ID Numbers: AnesthN-8-2018
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hisham Hosny, Cairo University:
Extravascular lung water
one lung ventilation
volume controlled ventilation
pressure controlled ventilation