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

Not Applicable

Completed

• Conditions: Low Tidal Volume Ventilation
• Interventions: Procedure: tidal volume ventilation

• Registration Number: NCT03467607
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study Start: 2016-10-20
• Primary Completion: 2017-03-10
• Study Completion: 2017-06-30
• Study First Submitted: 2018-01-19
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3ml/kg	tidal volume ventilation	15 patients ventilated with 3ml/kg ideal body weight while on one lung ventilation
control	tidal volume ventilation	15 patients ventilated using the anaesthetists usual ventilation strategy
4ml/kg	tidal volume ventilation	15 patients ventilated with 4ml/kg ideal body weight while on one lung ventilation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
length of icu stay	until patient discharge at 6 weeks post operatively	number of days in ICU
length of hospital stay	until patient discharge at 6 weeks post operatively	number of days in hospital
30 day mortality	30 days post operatively	number of patients who died within 30 days of their procedure

Trial Locations

Locations (1)

St James's Hospital Dublin; 🇮🇪 Dublin, Ireland