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

• Sponsor: University of Dublin, Trinity College (Other)
• Overall Status: Completed
• CT.gov ID: NCT03467607
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Tidal Volume Ventilation	Procedure: tidal volume ventilation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel assignmentparallel assignment
• Masking: None (Open Label)
• Masking Description: open label, randomisation blinded
• Primary Purpose: Prevention
• Official Title: A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation
• Actual Study Start Date: Oct 20, 2016
• Actual Primary Completion Date: Mar 10, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Radiological evidence of injury to the ventilated lung [post operatively up to 6 weeks post operatively]

   evidence of infiltrates in the non operative lung

2. unplanned ICU admission [up to 6 weeks post operatively]

   unplanned admission to the icu with respiratory issues

3. Requirement for non-invasive ventilation [up to 6 weeks post operatively]

   whether a patient in the trial requires niv for respiratory failure

4. Hospital acquired pneumonia [up to discharge at 6 weeks post operatively]

   pneumonia acquired in hospital

Secondary Outcome Measures

1. length of hospital stay [until patient discharge at 6 weeks post operatively]

   number of days in hospital

2. length of icu stay [until patient discharge at 6 weeks post operatively]

   number of days in ICU

3. 30 day mortality [30 days post operatively]

   number of patients who died within 30 days of their procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St James's Hospital Dublin	Dublin		Ireland

Sponsors and Collaborators

• University of Dublin, Trinity College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ignacio martin loeches, Consultant Intensivist, University of Dublin, Trinity College
• ClinicalTrials.gov Identifier: NCT03467607
• Other Study ID Numbers: 2016-11 List 43 (1)
• First Posted: Mar 16, 2018
• Last Update Posted: Mar 16, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 16, 2018