Non-dependent HFPPV Versus CPAP for Video-assisted Thoracoscopy

This study has been completed.
Sponsor:
Information provided by:
King Faisal University
ClinicalTrials.gov Identifier:
NCT01254786
First received: November 22, 2010
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

Video-assisted thoracoscopic surgery (VATS) is usually performed using well-collapsed lung is essential for optimum surgical visualization and resection. However, one lung ventilation (OLV) is associated with deleterious impaired oxygenation secondary to the increases in shunt fraction.1 There are different approaches for the recruitment of the non-dependent lung (NL) during OLV such as the selective application of continuous positive pressure ventilation (CPAP) or high frequency positive pressure ventilation (HFPPV) to the non-dependent lung.2-4 These strategies may improve arterial oxygenation and reduce shunt fraction,2-4 However, the use of high CPAP levels impaired the surgical conditions during thoracotomy.2-3 On contrary, the application of HFPPV either to both lungs5or to the non-dependent lung permits adequate surgical conditions during thoracotomy.4 The investigators hypothesize that the application of volume-controlled HFPPV to the non-dependent lung during OLV for video-assisted thoracoscopic surgery may provide better surgical field and adequate oxygenation than the use of CPAP 2 cm H2O.

The investigators will evaluate the effects of the selective application of conventional one lung ventilation, HFPPV, or CPAP 2 cm H2O to the non-dependent lung on surgical field conditions, and arterial oxygen and carbon dioxide tensions (PaO2 and PaCO2, respectively) during OLV in the patients scheduled for video-assisted thoracoscopic surgery.


Condition Intervention Phase
Elective Video-assisted Thoracoscopic Surgery
One-lung Ventilation Lasts at Least One Hour
Procedure: Non-dependent lung ventilation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of the Non-dependent Continuous Positive Pressure Ventilation and High Frequency Positive Pressure Ventilation During One-lung Ventilation for Thoracoscopy

Further study details as provided by King Faisal University:

Primary Outcome Measures:
  • Visual Analog Scale rating of the surgical field conditions [ Time Frame: every 15 min from the start of surgery ] [ Designated as safety issue: Yes ]
    Visual analog Scoring assesment of the surgical field conditions will be rated by the surgeons. VAS of 10 denotes the best surgical fied and VAS of 0 attributes inability to proceed with surgery


Secondary Outcome Measures:
  • Hemodynamic variables [ Time Frame: every 15 min from the start of surgery ] [ Designated as safety issue: Yes ]
    hemodynamic parameters (heart rate and mean arterial blood pressure)

  • Respiratory variables [ Time Frame: every 15 min from the start of surgery ] [ Designated as safety issue: Yes ]
    Respiration parameters (arterial carbon dioxide tensions (PaCO2)


Enrollment: 30
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP2 - HFPPV group
the non-dependent lung will be ventilated with CPAP of 2 cm H2O for 30 min followed with HFPPV for min.
Procedure: Non-dependent lung ventilation

the dependent lung will be ventilated with conventional ventilation (OLV) a tidal volume of 6 mL/kg (predicted body weight), whereas FiO2, I: E ratio, PEEP, frequency, peak inspiratory pressures, and a flow of fresh gas will be maintained as during two-lung ventilation for 15 min.

Then the non-dependent lung will be allowed to deflate to a CPAP of 2 cm H2O, which will be connected to the flowmeter of an oxygen cylinder with a flow rate of 5 L/min and FiO2 of 1.0 for 30 min

Then, the non-dependent lung will be connected to a second identical ventilator, 15 min after OLV, using a FiO2 of 1.0, VT 3 mL/kg (predicted body weight), I: E ratio <0.3 and R.R 60 breaths/min for further 30 min.

Active Comparator: HFPPV-CPAP2 group
the non-dependent lung will be ventilated with HFPPV for 30 min followed with CPAP of 2 cm H2O for 30 min.
Procedure: Non-dependent lung ventilation

the dependent lung will be ventilated with conventional ventilation (OLV) a tidal volume of 6 mL/kg (predicted body weight), whereas FiO2, I: E ratio, PEEP, frequency, peak inspiratory pressures, and a flow of fresh gas will be maintained as during two-lung ventilation for 15 min.

Then, the non-dependent lung will be connected to a second identical ventilator, 15 min after OLV, using a FiO2 of 1.0, VT 3 mL/kg (predicted body weight), I: E ratio <0.3 and R.R 60 breaths/min for further 30 min.

Then the non-dependent lung will be allowed to deflate to a CPAP of 2 cm H2O, which will be connected to the flowmeter of an oxygen cylinder with a flow rate of 5 L/min and FiO2 of 1.0 for 30 min


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective video-assisted thoracoscopic surgery with at least one hour of one-lung ventilation (OLV)

Exclusion Criteria:

  • decompensated cardiac diseases(>New York Heart Association II)
  • pulmonary diseases(vital capacity or FEV1% < 50% of the predicted values)
  • hepatic diseases
  • renal diseases
  • arrhythmias
  • pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg)
  • previous history of pneumonectomy
  • bilobectomy
  • 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: NCT01254786

Locations
Saudi Arabia
King Fahd hospital of the University of Dammam
Al Khubar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
King Faisal University
Investigators
Principal Investigator: Mohamed R El Tahan, M.D. University of Dammam
  More Information

No publications provided

Responsible Party: Dr. Mohamed El Tahan, University of Dammam
ClinicalTrials.gov Identifier: NCT01254786     History of Changes
Other Study ID Numbers: 201013
Study First Received: November 22, 2010
Last Updated: December 6, 2010
Health Authority: Saudi Arabia: Ministry for Higher Education

Keywords provided by King Faisal University:
VATS
one lung ventilation
continuous positive pressure ventilation
high frequency positive pressure ventilation

ClinicalTrials.gov processed this record on July 20, 2014