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

NCT ID: NCT03467607

Last Updated: 2018-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-20

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Low Tidal Volume Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

open label, randomisation blinded

Study Groups

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3ml/kg

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

Group Type ACTIVE_COMPARATOR

tidal volume ventilation

Intervention Type PROCEDURE

low tidal volume ventilation

4ml/kg

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

Group Type ACTIVE_COMPARATOR

tidal volume ventilation

Intervention Type PROCEDURE

low tidal volume ventilation

control

15 patients ventilated using the anaesthetists usual ventilation strategy

Group Type ACTIVE_COMPARATOR

tidal volume ventilation

Intervention Type PROCEDURE

low tidal volume ventilation

Interventions

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tidal volume ventilation

low tidal volume ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Dublin, Trinity College

OTHER

Sponsor Role lead

Responsible Party

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ignacio martin loeches

Consultant Intensivist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ignacio Martin-Loeches, md

Role: STUDY_CHAIR

University of Dublin, Trinity College

Locations

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St James's Hospital Dublin

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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2016-11 List 43 (1)

Identifier Type: -

Identifier Source: org_study_id

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