Non-dependent Lung High Frequency Positive Pressure Ventilation (HFPPV) and Right Ventricular Function

NCT01019993 | Completed Phase 1

• 1 other identifier: 39-01-2004
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Esophageal Diseases

Keywords

Thoracotomy; one lung ventilation; HFPPV; right ventricular function.

Outcome Measures

Primary Outcomes (1)

• Primary outcome variables included right ventricular function (REF, RVEDVI, and RVSWI).

  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 Outcomes (1)

• Secondary outcome variables were hemodynamic parameters (HR, MAP, CI, SVI, and PVRI), oxygenation parameters (DO2, VO2, and Qs:Qt) and surgical field conditions.

  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)

Study Arms (2)

good pulmonary functions (group N)

ACTIVE COMPARATOR

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

Procedure: conventional OLV followed with IL-HFPPV

pulmonary dysfunction (group PD)

ACTIVE COMPARATOR

The patients were allocated if they have FVC and/or FEV1 of 50%-79% of predicted

Procedure: conventional OLV followed with IL-HFPPV

Interventions

conventional OLV followed with IL-HFPPV PROCEDURE

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.

Also known as: KONTRON ABT 5300 ventilator, UK

good pulmonary functions (group N); pulmonary dysfunction (group PD)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal University: lead
• Mansoura University: collaborator

Study Sites (1)

Cardiothoracic Unit, Faculty of Medicine, Mansoura University, Egypt

Al Mansurah, DK, Egypt

Location

MeSH Terms

Conditions

Lung Diseases; Esophageal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mohamed R El Tahan, M.D.

  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

  PRINCIPAL INVESTIGATOR

• Reda A. Hamad, M.D.

  Cardiothoracic Unit, Faculty of Medicine, Mansoura University, Egypt (current affiliation: Prince Sultan Cardiac Centre, Riyadh, KSA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: February 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2007
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

EG (1)