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

NCT03467607 | Completed

• 1 other identifier: 2016-11 List 43 (1)
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Tidal Volume Ventilation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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 Arms (3)

3ml/kg

ACTIVE COMPARATOR

15 patients ventilated with 3ml/kg ideal body weight while on one lung ventilation

Procedure: tidal volume ventilation

4ml/kg

ACTIVE COMPARATOR

15 patients ventilated with 4ml/kg ideal body weight while on one lung ventilation

Procedure: tidal volume ventilation

control

ACTIVE COMPARATOR

15 patients ventilated using the anaesthetists usual ventilation strategy

Procedure: tidal volume ventilation

Interventions

tidal volume ventilation PROCEDURE

low tidal volume ventilation

3ml/kg; 4ml/kg; control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

St James's Hospital Dublin

Dublin, Ireland

Location

Study Officials

• Ignacio Martin-Loeches, md

  University of Dublin, Trinity College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label, randomisation blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Intensivist

Model Details: parallel assignment

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: March 16, 2018
• Study Start: October 20, 2016
• Primary Completion: March 10, 2017
• Study Completion: June 30, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)