Pressure-controlled vs Volume Controlled Ventilation on RV Function During OLV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT01763879
First received: December 30, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for thoracic surgery is associated with comparable oxygenation with volume controlled ventilation (VCV) with added benefits of decreasing airway pressures and shunt fraction. The later may improve the right ventricular (RV) function during OLV. We postulate that the use of PCV during OLV for thoracic surgery would preserve RV function than during VCV. After local ethics committee approval and informed consent, we will randomly allocate 28 patients scheduled for elective thoracic surgery OLV to randomly crossed from PCV to VCV mode (n= 14 for each) during with VT of 6 mL/kg, I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain normocapnia. Intraoperative changes in the right ventricular function (peak systolic and diastolic tricuspid annular velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area changes (RV-FAC)), hemodynamic and oxygenation parameters, peak and plateau airway pressures, compliance will be recorded.


Condition Intervention Phase
Lung Diseases
Other: The PCV-VCV group
Other: The VCV-PCV group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Right Ventricular Function During One-lung Ventilation: The Effects of Pressure Controlled and Volume Controlled Ventilation

Further study details as provided by Dammam University:

Primary Outcome Measures:
  • Right ventricular function [ Time Frame: Change from baseline at 30 min after the initiation of the intervention ] [ Designated as safety issue: Yes ]
    Peak systolic and diastolic tricuspid annular velocity (TAV)


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Change from baseline at 30 min after the initiation of the intervention ] [ Designated as safety issue: Yes ]
    Blood pressure

  • Pa/FiO2 ratio [ Time Frame: Change from baseline at 30 min after the initiation of the intervention ] [ Designated as safety issue: Yes ]
    the ratio between arterial oxygen tension (PaO2)and inspired fraction of oxygen (FiO2)

  • Airway pressures [ Time Frame: Change from baseline at 30 min after the initiation of the intervention ] [ Designated as safety issue: Yes ]
    Peak and plateau airway pressures

  • Right ventricular volumes [ Time Frame: Change from baseline at 30 min after the initiation of the intervention ] [ Designated as safety issue: Yes ]
    right ventricular end diastolic and systolic volumes


Enrollment: 28
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: The PCV-VCV group
The dependent lung will be ventilated with pressure controlled (PCV) followed by the volume-controlled ventilation (VCV)
Other: The PCV-VCV group
During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
Active Comparator: The VCV-PCV group
The dependent lung will be ventilated with volume-controlled ventilation (VCV) followed by the pressure controlled (PCV)
Other: The VCV-PCV group
During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical class from II to III

Exclusion Criteria:

  • decompensated cardiac (New York Heart Association >II)
  • pulmonary (vital capacity or FEV1% < 50% of the predicted values)
  • asthma
  • hepatic diseases.
  • renal diseases
  • arrhythmias
  • pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg)
  • body mass index >35 kg/m2
  • previous history of pneumonectomy, bilobectomy, or lobectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763879

Locations
Saudi Arabia
Anesthesiology Department
Al Khubar, Eastern, Saudi Arabia, 31592
Sponsors and Collaborators
Dammam University
Investigators
Study Director: Mohamed R El Tahan, MD Assistant Professor
Principal Investigator: Roshdi Al Metwally, MD Associate Professor
Study Chair: Hatem Qutub, MD Associate Professor
Study Chair: Yasser F El Ghoneimy, MD Associate Professor
Study Chair: Mohamed A Regal, MD Associate Professor
Study Chair: Haytham Zien, MD Assistant Professor
  More Information

No publications provided

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01763879     History of Changes
Other Study ID Numbers: 2012081, 2012081
Study First Received: December 30, 2012
Last Updated: July 24, 2013
Health Authority: Saudi Arabia: Ministry of Higher Education

Keywords provided by Dammam University:
Thoracic surgery
one lung ventilation
pressure-controlled ventilation
volume-controlled ventilation
right ventricular function

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014