Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

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

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-09-30

Brief Summary

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The purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.

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Detailed Description

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The proposed study is a randomized controlled trial of tracheal cuff pressure control using continuous control via an automated electronic device as compared with intermittent pressure control for the prevention of ventilator associated respiratory infection in ICU.

The study will be conducted at multiple sites in Vietnam. Recruitment will be for 18 months at all centers. Patients experiencing any hospital acquired infection whilst at risk of Ventilator Associated Respiratory Infections will be evaluated in using a standardised investigation protocol to identify cases of VARI and other hospital acquired infections (HAI)s. Assessment of VARI will be based on published criteria and carried out by an endpoint review committee independent of patient care and blinded to the allocation of the patient. Antibiotic use data and duration of stay will be important secondary outcome measures.

Conditions

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Mechanical Ventilation Complication Tracheal Intubation Morbidity Ventilator-Associated Pneumonia Hospital Acquired Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous Pressure Control (CPC)

Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.

Group Type EXPERIMENTAL

Tracoe cuff pressure controller

Intervention Type DEVICE

Participant will be attached to the cuff pressure controller as soon as possible after enrolment. They will remain attached during their intubated stay. If reintubated during same admission they will continue in the intervention arm. If readmitted to ICU they will be managed according to standard care.

Standard Care

Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tracoe cuff pressure controller

Participant will be attached to the cuff pressure controller as soon as possible after enrolment. They will remain attached during their intubated stay. If reintubated during same admission they will continue in the intervention arm. If readmitted to ICU they will be managed according to standard care.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
* For active treatment

Exclusion Criteria

* previously enrolled in this study
* previously intubated within 14 days
* suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No