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

NCT01763879 | Completed Phase 3 DMC

• 1 other identifier: 2012081
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Diseases

Keywords

Thoracic surgery; one lung ventilation; pressure-controlled ventilation; volume-controlled ventilation; right ventricular function

Outcome Measures

Primary Outcomes (1)

• Right ventricular function

  Peak systolic and diastolic tricuspid annular velocity (TAV)

  Change from baseline at 30 min after the initiation of the intervention

Secondary Outcomes (4)

• Blood pressure

  Change from baseline at 30 min after the initiation of the intervention

• Pa/FiO2 ratio

  Change from baseline at 30 min after the initiation of the intervention

• Airway pressures

  Change from baseline at 30 min after the initiation of the intervention

• Right ventricular volumes

  Change from baseline at 30 min after the initiation of the intervention

Study Arms (2)

The PCV-VCV group

ACTIVE COMPARATOR

The dependent lung will be ventilated with pressure controlled (PCV) followed by the volume-controlled ventilation (VCV)

Other: The PCV-VCV group

The VCV-PCV group

ACTIVE COMPARATOR

The dependent lung will be ventilated with volume-controlled ventilation (VCV) followed by the pressure controlled (PCV)

Other: The VCV-PCV group

Interventions

The PCV-VCV group OTHER

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.

The PCV-VCV group

The VCV-PCV group OTHER

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.

The VCV-PCV group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Anesthesiology Department

Khobar, Eastern Province, 31592, Saudi Arabia

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Mohamed R El Tahan, MD

  Assistant Professor

  STUDY DIRECTOR

• Roshdi Al Metwally, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 9, 2013
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

SA (1)