Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

Mechanical Ventilation Complication Clinical Trial

— VARI-prevent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966392
• Other study ID #: 16HN
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: September 2019

Study information

• Verified date: May 2020
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hospital Acquired Infection
• Infection
• Mechanical Ventilation Complication
• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Tract Infections
• Tracheal Intubation Morbidity
• Ventilator-Associated Pneumonia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Vietnam	National Hospital for Tropical Diseases	Hanoi
Vietnam	Hospital for Tropical Diseases	Ho Chi Minh City
Vietnam	Trung Vuong Hospital	Ho Chi Minh City

Sponsors (4)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, The National Hospital for Tropical Diseases, Ha Noi, Vietnam, Trung Vuong Hospital, Ho Chi Minh City, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Grade 3 &4 adverse events relating to endotracheal cuff pressure		From randomisation to 90 days
Primary	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	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
Secondary	Clinical and microbiologically confirmed VAP (see above for definitions)		From randomisation to ICU discharge/death/transfer or 90 days
Secondary	Intubated days receiving antibiotics		From randomisation to ICU discharge/death/transfer or 90 days
Secondary	Incidence of hospital acquired infection		From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days
Secondary	Total number of days ventilated/in ICU		From randomisation to ICU discharge, death, transfer or 90 days
Secondary	Cost of ICU stay		From ICU admission to ICU discharge, death, transfer or 90 days
Secondary	Cost of antibiotics in ICU stay		From ICU admission to ICU discharge, death, transfer or 90 days
Secondary	Cost of hospital stay		From hospital admission to hospital discharge or 90 days
Secondary	28 day mortality		From randomisation to 28 days after randomisation
Secondary	90 day mortality		From randomisation to 90 days after randomisation
Secondary	ICU mortality		From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Secondary	Hospital mortality		From randomisation to discharge from ICU or death/palliative discharge from it or 90 days