Pressure-Controlled vs Volume-Controlled Ventilation During One Lung Ventilation

NCT00975468 | Suspended DMC

• 2 other identifiers: PCV vs. VCV during OLV+966508491257
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Compared with the information available in sepsis and trauma-associated ARDS, less is known about the cause and pattern of lung injury after thoracic surgery. Definition of lung injury in this context is difficult. Most now use the joint North American-European consensus conference definitions, but these are based only on gas exchange and radiology criteria. While gas exchange measures are reliable, thoracotomy inevitably causes radiological change and the interpretation of plain chest films becomes subjective. Definitions based on permeability and inflammatory changes would improve diagnosis, but are not routinely available in most units. Pressure-controlled volume (PCV) may be useful to improve gas exchange and alveolar recruitment with associated lower airway pressures and shunt fraction during one-lung ventilation (OLV). However, a recent prospective randomized study of the effects of PCV during OLV did not lead to improved oxygenation during OLV compared with VCV, but PCV did lead to lower peak airway pressures. To date, there are no reports of the effects of PCV versus VCV during OLV on the acute lung injury (ALI) after thoracotomy.

Conditions

Thoracic Surgery

Keywords

pressure-controlled; volume-controlled; one lung; ventilation; lung injury; thoracotomy

Outcome Measures

Primary Outcomes (1)

• Determine changes in the serum levels of cytokines

  4 months

Secondary Outcomes (1)

• Arterial blood gases, chest X- ray, pulmonary function tests, samples collection [serum and BAL] and laboratory testing for cytokine changes, the times of ventilation, extubation, ICU and hospital stay, mortality and morbidity.

  10 months

Study Arms (2)

Pressure-Controlled Ventilation

ACTIVE COMPARATOR

The patients' lungs ventilation will be initiated with a peak airway pressure that provided a tidal volume of 8 ml.kg-1. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.

Other: Pressure Controlled vs. Volume Controlled Ventilation during OLV

Volume Controlled Ventilation

PLACEBO COMPARATOR

The patients' lungs will ventilated with a tidal volume of 8 ml.kg-1. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.

Other: Pressure Controlled vs. Volume Controlled Ventilation during OLV

Interventions

Pressure Controlled vs. Volume Controlled Ventilation during OLV OTHER

Ventilation will be initiated with a tidal volume of 8 ml.kg-1 in Volume-controlled group and with a peak airway pressure that provided a tidal volume of 8 ml.kg-1 in pressure-controlled group. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.

Pressure-Controlled Ventilation; Volume Controlled Ventilation

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-60 years (ASA physical status II-III) scheduled for elective open thoracic surgery using one lung ventilation for periods longer than 1.5 h

You may not qualify if:

• We will exclude the patients with:
• decompensated cardiac (\>New York Heart Association II)
• pulmonary diseases (VC or FEV1\<50% of the predicted values)
• pulmonary hypertension (mean pulmonary artery pressure \[MPAP\] \>30 mm Hg)
• previous lobectomy or bilobectomy in the medical history
• those treated with immune modulators (cytostatic drugs, corticosteroids and non-steroidal anti-inflammatory drugs, vaccination, blood products), within 3 months before surgery and with symptoms of an acute inflammatory process (clinically defined or abnormal data for C-reactive protein, leukocyte count, or body temperature)

Sponsors & Collaborators

• King Faisal University: lead

Study Sites (1)

King Fahd Hospital of the University

Dammam, Eastern Province, Saudi Arabia

Location

MeSH Terms

Conditions

Respiratory Aspiration; Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Mohamed Regal, M.D

  King Faisal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 11, 2009
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2023
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

SA (1)