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Clinical Trials/NCT03467607
NCT03467607
Completed
Not Applicable

A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation

University of Dublin, Trinity College1 site in 1 country45 target enrollmentOctober 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Tidal Volume Ventilation
Sponsor
University of Dublin, Trinity College
Enrollment
45
Locations
1
Primary Endpoint
Radiological evidence of injury to the ventilated lung
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

A study of two ventilatory strategies for low tidal volume ventilation compared to a control group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung ventilation.

Detailed Description

This study investigated the feasibility of low tidal volume ventilation for one lung ventilation. 45 patients were recruited - 15 patients in each of three groups, 3ml/kg, 4ml/kg or usual care. Outcomes studied were length of stay, 30 day mortality, unplanned ICU admission, evidence of respiratory failure or requirement for non-invasive ventilation, chest x-ray infiltrates and requirement for antibiotics.

Registry
clinicaltrials.gov
Start Date
October 20, 2016
End Date
June 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ignacio martin loeches

Consultant Intensivist

University of Dublin, Trinity College

Eligibility Criteria

Inclusion Criteria

  • ASA I-III lung resection surgery requiring one lung ventilation

Exclusion Criteria

  • ASA IV or above under 18 or over 80 years of age pregnancy previous lung lobectomy or pneumonectomy requirement for massive transfusion during the case BMI \> 35

Outcomes

Primary Outcomes

Radiological evidence of injury to the ventilated lung

Time Frame: post operatively up to 6 weeks post operatively

evidence of infiltrates in the non operative lung

unplanned ICU admission

Time Frame: up to 6 weeks post operatively

unplanned admission to the icu with respiratory issues

Requirement for non-invasive ventilation

Time Frame: up to 6 weeks post operatively

whether a patient in the trial requires niv for respiratory failure

Hospital acquired pneumonia

Time Frame: up to discharge at 6 weeks post operatively

pneumonia acquired in hospital

Secondary Outcomes

  • length of hospital stay(until patient discharge at 6 weeks post operatively)
  • length of icu stay(until patient discharge at 6 weeks post operatively)
  • 30 day mortality(30 days post operatively)

Study Sites (1)

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