Clinical trial NCT02966392: Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
Official title: A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Tracheal Intubation Morbidity
Ventilator-Associated Pneumonia
Hospital Acquired Infection
Keywords: Cuff pressure
Ventilator associated pneumonia
Respiratory tract infections
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
name: Trung Vuong Hospital, Ho Chi Minh City, Vietnam
name: The National Hospital for Tropical Diseases, Ha Noi, Vietnam
First posted: 2016-11-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)
timeFrame: From randomisation to ICU discharge/death/transfer or 90 days
Secondary outcomes:
measure: Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT
timeFrame: From randomisation to ICU discharge/death/transfer or 90 days
measure: Clinical and microbiologically confirmed VAP (see above for definitions)
timeFrame: From randomisation to ICU discharge/death/transfer or 90 days
measure: Intubated days receiving antibiotics
timeFrame: From randomisation to ICU discharge/death/transfer or 90 days
measure: Incidence of hospital acquired infection
timeFrame: From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days
measure: Total number of days ventilated/in ICU
timeFrame: From randomisation to ICU discharge, death, transfer or 90 days
measure: Cost of ICU stay
timeFrame: From ICU admission to ICU discharge, death, transfer or 90 days
measure: Cost of antibiotics in ICU stay
timeFrame: From ICU admission to ICU discharge, death, transfer or 90 days
measure: Cost of hospital stay
timeFrame: From hospital admission to hospital discharge or 90 days
measure: 28 day mortality
timeFrame: From randomisation to 28 days after randomisation
measure: 90 day mortality
timeFrame: From randomisation to 90 days after randomisation
measure: ICU mortality
timeFrame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
measure: Hospital mortality
timeFrame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Other outcomes:
measure: Grade 3 &4 adverse events relating to endotracheal cuff pressure
timeFrame: From randomisation to 90 days
Locations:
city: Hanoi
country: Vietnam
facility: National Hospital for Tropical Diseases
city: Ho Chi Minh City
country: Vietnam
facility: Hospital for Tropical Diseases
city: Ho Chi Minh City
country: Vietnam
facility: Trung Vuong Hospital
Study officials:
affiliation: Oxford University Clinical Research Unit
name: Behzad Nadjm, MBChB MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dat 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.