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Clinical Trials/NCT01513018
NCT01513018
Completed
Not Applicable

Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation

The Cleveland Clinic1 site in 1 country100 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Lung Injury
Sponsor
The Cleveland Clinic
Enrollment
100
Locations
1
Primary Endpoint
low (5ml/kg) tidal volume on arterial oxygenation
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV.

One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P < 0.05 was considered statistically significant.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
September 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ASA I-III patients scheduled for lung resection surgery.

Exclusion Criteria

  • severe cardiovascular disease
  • severe alteration of the preoperative pulmonary function, with FEV1 70-120% predicted and FEV1/FVC ≥ 70% predicted considered to be normal.

Outcomes

Primary Outcomes

low (5ml/kg) tidal volume on arterial oxygenation

Time Frame: 30 minutes of ventillation

Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.

high (10 ml/kg) tidal volumes on arterial oxygenation

Time Frame: 30 minutes of ventillation

Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.

low (5 ml/kg)tidal volumes on Intrapulmonary shunt

Time Frame: 30 minutes of ventillation

Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.

high (10 ml/kg) tidal volumes on Intrapulmonary shunt

Time Frame: 30 minutes of ventillation

Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.

Study Sites (1)

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