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

NCT01513018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-01-20

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Tamás Végh, M.D. · Klinikum Ludwigshafen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513018 on ClinicalTrials.gov