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

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.

Study Overview

• Status: Completed
• Conditions: Low Tidal Volume Ventilation
• Intervention / Treatment: Procedure: tidal volume 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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St James's Hospital Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Investigators: Study Chair: Ignacio Martin-Loeches, md, University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): March 10, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2016-11 List 43 (1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No