Non-dependent Lung High Frequency Positive Pressure Ventilation (HFPPV) and Right Ventricular Function
Primary Purpose
Lung Diseases, Esophageal Diseases
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
conventional OLV followed with IL-HFPPV
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring Thoracotomy, one lung ventilation, HFPPV, right ventricular function.
Eligibility Criteria
Inclusion Criteria:
- Thirty-three patients ASA physical status II-III) scheduled for elective open thoracic surgery were prospectively included in this study at the authors' cardiothoracic center. Approval of the institutional ethical committee and informed written consent was obtained specifically for use of pulmonary artery catheter which is not routinely used in thoracic procedures at the authors' center.
Exclusion Criteria:
- Patients with decompensated cardiac (> New York Heart Association II), pulmonary (vital capacity or FEV1% < 50% of the predicted values), hepatic, and renal diseases, arrhythmias, pulmonary hypertension (mean pulmonary artery pressure (MPAP) > 30 mm Hg), and previous history of pneumonectomy, bilobectomy or lobectomy.
Sites / Locations
- Cardiothoracic Unit, Faculty of Medicine, Mansoura University, Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
good pulmonary functions (group N)
pulmonary dysfunction (group PD)
Arm Description
The patients were allocated if they have forced vital capacity (FVC %) and/or forced expiratory volume in 1 sec (FEV1%) of 80% of predicted or more
The patients were allocated if they have FVC and/or FEV1 of 50%-79% of predicted
Outcomes
Primary Outcome Measures
Primary outcome variables included right ventricular function (REF, RVEDVI, and RVSWI).
Secondary Outcome Measures
Secondary outcome variables were hemodynamic parameters (HR, MAP, CI, SVI, and PVRI), oxygenation parameters (DO2, VO2, and Qs:Qt) and surgical field conditions.
Full Information
NCT ID
NCT01019993
First Posted
November 24, 2009
Last Updated
May 26, 2010
Sponsor
King Faisal University
Collaborators
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT01019993
Brief Title
Non-dependent Lung High Frequency Positive Pressure Ventilation (HFPPV) and Right Ventricular Function
Official Title
Prospective Study of the Effects of Non-dependent Lung High Frequency Positive Pressure Ventilation on the Right Ventricular Function for Thoracotomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King Faisal University
Collaborators
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesized that the application of volume-controlled HFPPV to the non-dependent lung during one-lung ventilation (OLV) for thoracotomy in patients with good pulmonary functions and mild-to-moderate pulmonary dysfunction may provide preservation of the right ventricular (RV) function, adequate oxygenation and optimum surgical conditions.
The investigators evaluated the effects of IL-HFPPV on RV ejection fraction (REF), RV end-diastolic volume (RVEDVI), RV stroke work (RVSWI), pulmonary vascular resistance (PVRI), and stroke volume (SVI) indices, oxygen delivery (DO2) and uptake (VO2), shunt fraction (Qs: Qt), and surgical field conditions during OLV for thoracotomy in patients with good and mild-to-moderate impaired pulmonary functions.
Detailed Description
One-lung ventilation (OLV) provides an adequate operative field, but is opposed by the induced hypoxic pulmonary vasoconstriction (HPV) in the non-ventilated lung. It may preserve overall oxygen delivery, however with deleterious increase in shunt fraction and pulmonary vascular resistance.1-2Right ventricular (RV) overload resulting from these increases in its afterload influences postoperative morbidity and mortality. Intrinsic positive end-expiratory pressure (PEEPi) occurs frequently during OLV for thoracic surgery in the dependent lung of patients with pulmonary hyperinflation as opposed to patients with normal pulmonary function.3 The different approaches for the correction of hypoxemia during OLV may require some degree of recruitment of the non-dependent lung (IL), with different maneuvers such as the application of continuous positive pressure ventilation (CPAP) or high frequency jet ventilation (HFJV) to the non-dependent lung. These recruitment strategies, although they may improve arterial saturation, may concurrently decrease cardiac output, therefore having contradictory effects on overall oxygen delivery.4-6 Gas trapping may occur with increased ventilatory frequency during HFJV. This may impair RVEF through the increases in RV afterload.7 Therefore, the use of high frequency positive pressure ventilation (HFPPV) using tidal volumes just greater than the dead space increases arterial oxygen tension (PaO2) and the carbon dioxide excretion (VCO2) linearly with increasing peak airway pressure.8 We hypothesized that the application of volume-controlled HFPPV to the non-dependent lung during OLV for thoracotomy in patients with good pulmonary functions and mild-to-moderate pulmonary dysfunction may provide preservation of the RV function, adequate oxygenation and optimum surgical conditions.
We evaluated the effects of IL-HFPPV on RV ejection fraction (REF), RV end-diastolic volume (RVEDVI), RV stroke work (RVSWI), pulmonary vascular resistance (PVRI), and stroke volume (SVI) indices, oxygen delivery (DO2) and uptake (VO2), shunt fraction (Qs: Qt), and surgical field conditions during OLV for thoracotomy in patients with good and mild-to-moderate impaired pulmonary functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Esophageal Diseases
Keywords
Thoracotomy, one lung ventilation, HFPPV, right ventricular function.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
good pulmonary functions (group N)
Arm Type
Active Comparator
Arm Description
The patients were allocated if they have forced vital capacity (FVC %) and/or forced expiratory volume in 1 sec (FEV1%) of 80% of predicted or more
Arm Title
pulmonary dysfunction (group PD)
Arm Type
Active Comparator
Arm Description
The patients were allocated if they have FVC and/or FEV1 of 50%-79% of predicted
Intervention Type
Procedure
Intervention Name(s)
conventional OLV followed with IL-HFPPV
Other Intervention Name(s)
KONTRON ABT 5300 ventilator, UK
Intervention Description
The patients' lungs were mechanically ventilated with intermittent positive pressure ventilation using fraction of inspired oxygen (FiO2) of 0.5 in air, tidal volume (VT) of 8 mL/kg, inspiratory to expiratory [I: E] ratio of 1:2.5, zero positive end-expiratory pressure (PEEP), respiratory rate (R.R) was adjusted to achieve an arterial carbon dioxide tension (PaCO2) 35-45 mm Hg and peak inspiratory pressures were limited to 35 cm H2O. After pleurotomy, OLV was initiated with the same ventilatory settings for the dependent lung. After 30 min, the non-dependent collapsed lung was ventilated using HFPPV mode (IL-HFPPV) with another identical ventilator, with an internal circuit of low compliance, using FiO2 of 0.5 in air, VT 3 mL/kg, I: E ratio <0.3 and R.R 60 breaths/min.
Primary Outcome Measure Information:
Title
Primary outcome variables included right ventricular function (REF, RVEDVI, and RVSWI).
Time Frame
before (Baseline) and10 min after induction of anesthesia during two-lung ventilation, 15 and 30 min after OLV, 15, 30, 60 min after IL-HFPPV, and 15 min after resuming of two-lung ventilation (TLV
Secondary Outcome Measure Information:
Title
Secondary outcome variables were hemodynamic parameters (HR, MAP, CI, SVI, and PVRI), oxygenation parameters (DO2, VO2, and Qs:Qt) and surgical field conditions.
Time Frame
before (Baseline) and10 min after induction of anesthesia during two-lung ventilation, 15 and 30 min after OLV, 15, 30, 60 min after IL-HFPPV, and 15 min after resuming of two-lung ventilation (TLV)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thirty-three patients ASA physical status II-III) scheduled for elective open thoracic surgery were prospectively included in this study at the authors' cardiothoracic center. Approval of the institutional ethical committee and informed written consent was obtained specifically for use of pulmonary artery catheter which is not routinely used in thoracic procedures at the authors' center.
Exclusion Criteria:
Patients with decompensated cardiac (> New York Heart Association II), pulmonary (vital capacity or FEV1% < 50% of the predicted values), hepatic, and renal diseases, arrhythmias, pulmonary hypertension (mean pulmonary artery pressure (MPAP) > 30 mm Hg), and previous history of pneumonectomy, bilobectomy or lobectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed R El Tahan, M.D.
Organizational Affiliation
Anaesthesia and Surgical ICU, Faculty of Medicine, Mansoura University, Egypt (current affiliation: Department of Anaesthesia and Surgical ICU, Faculty of Medicine, King Faisal University, Dammam, KSA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reda A. Hamad, M.D.
Organizational Affiliation
Cardiothoracic Unit, Faculty of Medicine, Mansoura University, Egypt (current affiliation: Prince Sultan Cardiac Centre, Riyadh, KSA
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiothoracic Unit, Faculty of Medicine, Mansoura University, Egypt
City
Mansoura
State/Province
DK
Country
Egypt
12. IPD Sharing Statement
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Non-dependent Lung High Frequency Positive Pressure Ventilation (HFPPV) and Right Ventricular Function
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