Effect of PCV and VCV on Extravascular Lung Water

• ClinicalTrials.gov Identifier: NCT03514706
• Recruitment Status: Completed
• First Posted: May 2, 2018
• Last Update Posted: March 5, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Hisham Hosny, Cairo University

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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.

• 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
• Actual Primary Completion Date: January 1, 2019
• Actual Study Completion Date: March 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 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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

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

More Information

• 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: March 5, 2019
• Last Verified: March 2019

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