Effect of PCV and VCV on Extravascular Lung Water

NCT03514706 | Completed DMC

• 1 other identifier: AnesthN-8-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Extravascular Lung Water

Keywords

Extravascular lung water; one lung ventilation; volume controlled ventilation; pressure controlled ventilation

Outcome Measures

Primary Outcomes (1)

• Lung ultrasound score

  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

Study Arms (2)

Volume controlled ventilation

EXPERIMENTAL

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

Diagnostic Test: volume controlled ventilation

Pressure controlled ventilation

EXPERIMENTAL

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

Interventions

volume controlled ventilation DIAGNOSTIC_TEST

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

Also known as: LUS

Volume controlled ventilation

pressure controlled ventilation DIAGNOSTIC_TEST

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

Also known as: LUS

Pressure controlled ventilation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al-Ainy faculty of medicine. Cairo University

Cairo, 11516, Egypt

Location

Study Officials

• Hisham Hosny, MD

  Kasr Al-Ainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Lung ultrasound will be done by an investigator blinded to group allocation
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: May 2, 2018
• Study Start: March 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)