Non-dependent HFPPV Versus CPAP for Video-assisted Thoracoscopy

NCT01254786 | Completed Phase 2 DMC

• 1 other identifier: 201013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elective Video-assisted Thoracoscopic Surgery; One-lung Ventilation Lasts at Least One Hour

Keywords

VATS; one lung ventilation; continuous positive pressure ventilation; high frequency positive pressure ventilation

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale rating of the surgical field conditions

  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

  every 15 min from the start of surgery

Secondary Outcomes (2)

• Hemodynamic variables

  every 15 min from the start of surgery

• Respiratory variables

  every 15 min from the start of surgery

Study Arms (2)

CPAP2 - HFPPV group

ACTIVE COMPARATOR

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

HFPPV-CPAP2 group

ACTIVE COMPARATOR

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

Interventions

Non-dependent lung ventilation PROCEDURE

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.

CPAP2 - HFPPV group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Faisal University: lead

Study Sites (1)

King Fahd hospital of the University of Dammam

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Study Officials

• Mohamed R El Tahan, M.D.

  Imam Abdulrahman Bin Faisal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 7, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

SA (1)