Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

Study Overview
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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.

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.

Official Title
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A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections

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

Intervention / Treatment
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* Device: Tracoe cuff pressure controller


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Pressure Control (CPC)<br>Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU. | Device: Tracoe cuff pressure controller<br>* 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.<br>|
| No Intervention: Standard Care<br>Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT) |  | From randomisation to ICU discharge/death/transfer or 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT |  | From randomisation to ICU discharge/death/transfer or 90 days | 
| Clinical and microbiologically confirmed VAP (see above for definitions) |  | From randomisation to ICU discharge/death/transfer or 90 days | 
| Intubated days receiving antibiotics |  | From randomisation to ICU discharge/death/transfer or 90 days | 
| Incidence of hospital acquired infection |  | From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days | 
| Total number of days ventilated/in ICU |  | From randomisation to ICU discharge, death, transfer or 90 days | 
| Cost of ICU stay |  | From ICU admission to ICU discharge, death, transfer or 90 days | 
| Cost of antibiotics in ICU stay |  | From ICU admission to ICU discharge, death, transfer or 90 days | 
| Cost of hospital stay |  | From hospital admission to hospital discharge or 90 days | 
| 28 day mortality |  | From randomisation to 28 days after randomisation | 
| 90 day mortality |  | From randomisation to 90 days after randomisation | 
| ICU mortality |  | From randomisation to discharge from ICU or death/palliative discharge from it or 90 days | 
| Hospital mortality |  | From randomisation to discharge from ICU or death/palliative discharge from it or 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cuff pressure, Ventilator associated pneumonia, Respiratory tract infections