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

Not Applicable

Completed

• Conditions: Postoperative Lung Injury
• Interventions: Other: high tidal volumes; Other: low tidal volume

• Registration Number: NCT01513018
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Last Update Submitted: 2012-01-19
• Study First Posted: 2012-01-20
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
high (10 ml/kg) tidal volumes	high tidal volumes	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 tidal volume (5 ml/kg)	low tidal volume	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.

Primary Outcome Measures

Name	Time	Method
low (5ml/kg) tidal volume on arterial oxygenation	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	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	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	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.

Trial Locations

Locations (1)

University of Debrecen, Medical and Health Science CenterDepartment of Anesthesiology and Intensive Care; 🇭🇺 Debrecen, Hungary