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Trial record 1 of 1 for:    NCT02966392
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Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections (VARI-prevent)

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ClinicalTrials.gov Identifier: NCT02966392
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Trung Vuong Hospital, Ho Chi Minh City, Vietnam
The National Hospital for Tropical Diseases, Ha Noi, Vietnam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Tracheal Intubation Morbidity Ventilator-Associated Pneumonia Hospital Acquired Infection Device: Tracoe cuff pressure controller Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Continuous Pressure Control (CPC)
Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.
 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.
No Intervention: Standard Care
Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care)


Outcome Measures
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Primary Outcome Measures :
  1. Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT) [ Time Frame: From randomisation to ICU discharge/death/transfer or 90 days ]

Secondary Outcome Measures :
  1. Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT [ Time Frame: From randomisation to ICU discharge/death/transfer or 90 days ]
  2. Clinical and microbiologically confirmed VAP (see above for definitions) [ Time Frame: From randomisation to ICU discharge/death/transfer or 90 days ]
  3. Intubated days receiving antibiotics [ Time Frame: From randomisation to ICU discharge/death/transfer or 90 days ]
  4. Incidence of hospital acquired infection [ Time Frame: From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days ]
  5. Total number of days ventilated/in ICU [ Time Frame: From randomisation to ICU discharge, death, transfer or 90 days ]
  6. Cost of ICU stay [ Time Frame: From ICU admission to ICU discharge, death, transfer or 90 days ]
  7. Cost of antibiotics in ICU stay [ Time Frame: From ICU admission to ICU discharge, death, transfer or 90 days ]
  8. Cost of hospital stay [ Time Frame: From hospital admission to hospital discharge or 90 days ]
  9. 28 day mortality [ Time Frame: From randomisation to 28 days after randomisation ]
  10. 90 day mortality [ Time Frame: From randomisation to 90 days after randomisation ]
  11. ICU mortality [ Time Frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days ]
  12. Hospital mortality [ Time Frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days ]

Other Outcome Measures:
  1. Grade 3 &4 adverse events relating to endotracheal cuff pressure [ Time Frame: From randomisation to 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966392


Locations
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Vietnam
National Hospital for Tropical Diseases
Hanoi, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
Trung Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Trung Vuong Hospital, Ho Chi Minh City, Vietnam
The National Hospital for Tropical Diseases, Ha Noi, Vietnam
Investigators
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Principal Investigator: Behzad Nadjm, MBChB MD Oxford University Clinical Research Unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT02966392    
Other Study ID Numbers: 16HN
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We hope to share IPD, however the framework to do so is not yet finalised with our collaborating institutions
Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Cuff pressure
Ventilator associated pneumonia
Respiratory tract infections
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pneumonia
Respiratory Tract Infections
Pneumonia, Ventilator-Associated
Disease Attributes
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Healthcare-Associated Pneumonia
Cross Infection
Iatrogenic Disease