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

NCT01513018 | Completed

• 1 other identifier: DEOEC RKEB/IKEB 2976-2009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Lung Injury

Keywords

OLV; one lung ventilation

Outcome Measures

Primary Outcomes (4)

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

  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.

  30 minutes of ventillation

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

  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.

  30 minutes of ventillation

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

  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.

  30 minutes of ventillation

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

  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.

  30 minutes of ventillation

Study Arms (2)

high (10 ml/kg) tidal volumes

ACTIVE COMPARATOR

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.

Other: high tidal volumes

low tidal volume (5 ml/kg)

ACTIVE COMPARATOR

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.

Other: low tidal volume

Interventions

high tidal volumes OTHER

One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition. Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used.

high (10 ml/kg) tidal volumes

low tidal volume OTHER

One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition. Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used.

low tidal volume (5 ml/kg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

University of Debrecen, Medical and Health Science CenterDepartment of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

Location

Study Officials

• Tamás Végh, M.D.

  Klinikum Ludwigshafen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

HU (1)