Mechanical Ventilation ComplicationVARI-preventNCT02966392
Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
A study of Mechanical Ventilation Complication and Tracheal Intubation Morbidity, run by Oxford University Clinical Research Unit, Vietnam at 3 sites in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Tracheal Intubation Morbidity, Ventilator-Associated Pneumonia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesVietnam
- Study dates
- 1 Nov 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
- For active treatment
Who cannot join
- previously enrolled in this study
- previously intubated within 14 days
- suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
National Hospital for Tropical Diseases
Hanoi
Hospital for Tropical Diseases
Ho Chi Minh City
Trung Vuong Hospital
Ho Chi Minh City
About this study
Official title: A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
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.
Read the 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.
- Conditions
- Mechanical Ventilation Complication, Tracheal Intubation Morbidity, Ventilator-Associated Pneumonia, Hospital Acquired Infection
- Being tested
- Tracoe cuff pressure controller
- Keywords
- Cuff pressure, Ventilator associated pneumonia, Respiratory tract infections
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracoe cuff pressure controllerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Pressure Control (CPC) | Experimental | Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU. Receives: Device: Tracoe cuff pressure controller |
| Standard Care | No intervention | Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)
Measured: From randomisation to ICU discharge/death/transfer or 90 days
Secondary outcomes (12)
Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT
Measured: From randomisation to ICU discharge/death/transfer or 90 days
Clinical and microbiologically confirmed VAP (see above for definitions)
Measured: From randomisation to ICU discharge/death/transfer or 90 days
Intubated days receiving antibiotics
Measured: From randomisation to ICU discharge/death/transfer or 90 days
Incidence of hospital acquired infection
Measured: From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days
Total number of days ventilated/in ICU
Measured: From randomisation to ICU discharge, death, transfer or 90 days
Cost of ICU stay
Measured: From ICU admission to ICU discharge, death, transfer or 90 days
Cost of antibiotics in ICU stay
Measured: From ICU admission to ICU discharge, death, transfer or 90 days
Cost of hospital stay
Measured: From hospital admission to hospital discharge or 90 days
28 day mortality
Measured: From randomisation to 28 days after randomisation
90 day mortality
Measured: From randomisation to 90 days after randomisation
ICU mortality
Measured: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Hospital mortality
Measured: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start1 Nov 2016
- Primary completion7 Mar 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Behzad Nadjm, MBChB MD, Principal investigator, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966392
- Sponsor's protocol ID
- 16HN
- Acronym
- VARI-prevent
- Status last verified
- May 2020
- First submitted
- 9 Nov 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We hope to share IPD, however the framework to do so is not yet finalised with our collaborating institutions
Publications
Dat VQ, Minh Yen L, Thi Loan H, Dinh Phu V, Thien Binh N, Geskus RB, Khanh Trinh DH, Hoang Mai NT, Hoan Phu N, Huong Lan NP, Phuong Thuy T, Vu Trung N, Trung Cap N, Tuyet Trinh D, Thi Hoa N, Thi Thu Van N, Luan VTT, Quynh Nhu TT, Bao Long H, Thanh Ha NT, Thi Thanh Van N, Campbell J, Ahmadnia E, Kestelyn E, Wyncoll D, Thwaites GE, Van Hao N, Chien LT, Van Kinh N, Vinh Chau NV, van Doorn HR, Thwaites CL, Nadjm B. Effectiveness of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator-Associated Respiratory Infections: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2022 May 30;74(10):1795-1803. doi: 10.1093/cid/ciab724.
PubMed 34420048Dat VQ, Geskus RB, Wolbers M, Loan HT, Yen LM, Binh NT, Chien LT, Mai NTH, Phu NH, Lan NPH, Hao NV, Long HB, Thuy TP, Kinh NV, Trung NV, Phu VD, Cap NT, Trinh DT, Campbell J, Kestelyn E, Wertheim HFL, Wyncoll D, Thwaites GE, van Doorn HR, Thwaites CL, Nadjm B. Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial. Trials. 2018 Apr 4;19(1):217. doi: 10.1186/s13063-018-2587-6.
PubMed 29615093
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
- ClinicalTrials.gov ID
- NCT02966392
- Acronym / sponsor ID
- VARI-prevent / 16HN
- Conditions
- Mechanical Ventilation Complication, Tracheal Intubation Morbidity, Ventilator-Associated Pneumonia, Hospital Acquired Infection
- Keywords
- Cuff pressure, Ventilator associated pneumonia, Respiratory tract infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Pressure Control (CPC) | Experimental | Device: Tracoe cuff pressure controllerContinuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU. |
| Standard Care | No intervention | –Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
- For active treatment
Key exclusion criteria (3 listed)
- previously enrolled in this study
- previously intubated within 14 days
- suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracoe cuff pressure controllerParticipant 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. | Device | Continuous Pressure Control (CPC) |
Primary outcome
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
12 secondary outcomes
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
Clinical and microbiologically confirmed VAP (see above for definitions)
Time frame: From randomisation to ICU discharge/death/transfer or 90 days
Intubated days receiving antibiotics
Time frame: From randomisation to ICU discharge/death/transfer or 90 days
Incidence of hospital acquired infection
Time frame: From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days
Total number of days ventilated/in ICU
Time frame: From randomisation to ICU discharge, death, transfer or 90 days
Cost of ICU stay
Time frame: From ICU admission to ICU discharge, death, transfer or 90 days
Cost of antibiotics in ICU stay
Time frame: From ICU admission to ICU discharge, death, transfer or 90 days
Cost of hospital stay
Time frame: From hospital admission to hospital discharge or 90 days
28 day mortality
Time frame: From randomisation to 28 days after randomisation
90 day mortality
Time frame: From randomisation to 90 days after randomisation
ICU mortality
Time frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Hospital mortality
Time frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 34420048Dat VQ, Minh Yen L, Thi Loan H, Dinh Phu V, Thien Binh N, Geskus RB, Khanh Trinh DH, Hoang Mai NT, Hoan Phu N, Huong Lan NP, Phuong Thuy T, Vu Trung N, Trung Cap N, Tuyet Trinh D, Thi Hoa N, Thi Thu Van N, Luan VTT, Quynh Nhu TT, Bao Long H, Thanh Ha NT, Thi Thanh Van N, Campbell J, Ahmadnia E, Kestelyn E, Wyncoll D, Thwaites GE, Van Hao N, Chien LT, Van Kinh N, Vinh Chau NV, van Doorn HR, Thwaites CL, Nadjm B. Effectiveness of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator-Associated Respiratory Infections: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2022 May 30;74(10):1795-1803. doi: 10.1093/cid/ciab724.
- Derived from this study: PubMed 29615093Dat VQ, Geskus RB, Wolbers M, Loan HT, Yen LM, Binh NT, Chien LT, Mai NTH, Phu NH, Lan NPH, Hao NV, Long HB, Thuy TP, Kinh NV, Trung NV, Phu VD, Cap NT, Trinh DT, Campbell J, Kestelyn E, Wertheim HFL, Wyncoll D, Thwaites GE, van Doorn HR, Thwaites CL, Nadjm B. Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial. Trials. 2018 Apr 4;19(1):217. doi: 10.1186/s13063-018-2587-6.
- Individual participant dataSharing planned: Undecided. We hope to share IPD, however the framework to do so is not yet finalised with our collaborating institutions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behzad Nadjm, MBChB MD principal investigator
Oxford University Clinical Research Unit
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mechanical Ventilation Complication and Tracheal Intubation Morbidity, run by Oxford University Clinical Research Unit, Vietnam at 3 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966392, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.