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

Low Tidal Volume Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467607
• Other study ID #: 2016-11 List 43 (1)
• Status: Completed
• Phase: N/A
• First received: January 19, 2018
• Last updated: March 9, 2018
• Start date: October 20, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2018
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 30, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Tidal Volume Ventilation

Intervention

Procedure:
• tidal volume ventilation
low tidal volume ventilation

Locations

Country	Name	City	State
Ireland	St James's Hospital Dublin	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological evidence of injury to the ventilated lung	evidence of infiltrates in the non operative lung	post operatively up to 6 weeks post operatively
Primary	unplanned ICU admission	unplanned admission to the icu with respiratory issues	up to 6 weeks post operatively
Primary	Requirement for non-invasive ventilation	whether a patient in the trial requires niv for respiratory failure	up to 6 weeks post operatively
Primary	Hospital acquired pneumonia	pneumonia acquired in hospital	up to discharge at 6 weeks post operatively
Secondary	length of hospital stay	number of days in hospital	until patient discharge at 6 weeks post operatively
Secondary	length of icu stay	number of days in ICU	until patient discharge at 6 weeks post operatively
Secondary	30 day mortality	number of patients who died within 30 days of their procedure	30 days post operatively