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Completed

NCT Number: NCT03467607

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.

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Key information

Conditions

Low Tidal Volume Ventilation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St James's Hospital Dublin

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tidal volume ventilation

Procedure

low tidal volume ventilation

Primary outcomes

  1. Radiological evidence of injury to the ventilated lung

    Time frame: post operatively up to 6 weeks post operatively

    evidence of infiltrates in the non operative lung

  2. unplanned ICU admission

    Time frame: up to 6 weeks post operatively

    unplanned admission to the icu with respiratory issues

  3. Requirement for non-invasive ventilation

    Time frame: up to 6 weeks post operatively

    whether a patient in the trial requires niv for respiratory failure

  4. Hospital acquired pneumonia

    Time frame: up to discharge at 6 weeks post operatively

    pneumonia acquired in hospital

Secondary outcomes

  1. length of hospital stay

    Time frame: until patient discharge at 6 weeks post operatively

    number of days in hospital

  2. length of icu stay

    Time frame: until patient discharge at 6 weeks post operatively

    number of days in ICU

  3. 30 day mortality

    Time frame: 30 days post operatively

    number of patients who died within 30 days of their procedure

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2018
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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