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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Tidal Volume Ventilation

Intervention / Treatment
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* Procedure: tidal volume ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3ml/kg<br>15 patients ventilated with 3ml/kg ideal body weight while on one lung ventilation | Procedure: tidal volume ventilation<br>* low tidal volume ventilation<br>|
| Active Comparator: 4ml/kg<br>15 patients ventilated with 4ml/kg ideal body weight while on one lung ventilation | Procedure: tidal volume ventilation<br>* low tidal volume ventilation<br>|
| Active Comparator: control<br>15 patients ventilated using the anaesthetists usual ventilation strategy | Procedure: tidal volume ventilation<br>* low tidal volume ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological evidence of injury to the ventilated lung | evidence of infiltrates in the non operative lung | post operatively up to 6 weeks post operatively | 
| unplanned ICU admission | unplanned admission to the icu with respiratory issues | up to 6 weeks post operatively | 
| Requirement for non-invasive ventilation | whether a patient in the trial requires niv for respiratory failure | up to 6 weeks post operatively | 
| Hospital acquired pneumonia | pneumonia acquired in hospital | up to discharge at 6 weeks post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | number of days in hospital | until patient discharge at 6 weeks post operatively | 
| length of icu stay | number of days in ICU | until patient discharge at 6 weeks post operatively | 
| 30 day mortality | number of patients who died within 30 days of their procedure | 30 days post operatively |