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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03467607
Enrollment
45
Registered
2018-03-16
Start date
2016-10-20
Completion date
2017-06-30
Last updated
2018-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Tidal Volume Ventilation

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.

Interventions

PROCEDUREtidal volume ventilation

low tidal volume ventilation

Sponsors

University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

open label, randomisation blinded

Intervention model description

parallel assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Radiological evidence of injury to the ventilated lungpost operatively up to 6 weeks post operativelyevidence of infiltrates in the non operative lung
unplanned ICU admissionup to 6 weeks post operativelyunplanned admission to the icu with respiratory issues
Requirement for non-invasive ventilationup to 6 weeks post operativelywhether a patient in the trial requires niv for respiratory failure
Hospital acquired pneumoniaup to discharge at 6 weeks post operativelypneumonia acquired in hospital

Secondary

MeasureTime frameDescription
length of icu stayuntil patient discharge at 6 weeks post operativelynumber of days in ICU
30 day mortality30 days post operativelynumber of patients who died within 30 days of their procedure
length of hospital stayuntil patient discharge at 6 weeks post operativelynumber of days in hospital

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026