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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513018
First Posted: January 20, 2012
Last Update Posted: January 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose

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.


Condition Intervention
Postoperative Lung Injury Other: high tidal volumes Other: low tidal volume

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: high (10 ml/kg) 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.
Other: high tidal volumes

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.

Active Comparator: low tidal volume (5 ml/kg)
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

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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513018


Locations
Hungary
University of Debrecen, Medical and Health Science CenterDepartment of Anesthesiology and Intensive Care
Debrecen, Hungary, 4032
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Tamás Végh, M.D. Klinikum Ludwigshafen
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01513018     History of Changes
Other Study ID Numbers: DEOEC RKEB/IKEB 2976-2009
First Submitted: January 16, 2012
First Posted: January 20, 2012
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by The Cleveland Clinic:
OLV
one lung ventilation

Additional relevant MeSH terms:
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries