Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial

Abstract

Background: Ventilator-associated respiratory infection (VARI) comprises ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). Although their diagnostic criteria vary, together these are the most common hospital-acquired infections in intensive care units (ICUs) worldwide, responsible for a large proportion of antibiotic use within ICUs. Evidence-based strategies for the prevention of VARI in resource-limited settings are lacking. Preventing the leakage of oropharyngeal secretions into the lung using continuous endotracheal cuff pressure control is a promising strategy. The aim of this study is to investigate the efficacy of automated, continuous endotracheal cuff pressure control in preventing the development of VARI and reducing antibiotic use in ICUs in Vietnam.

Methods/design: This is an open-label randomised controlled multicentre trial. We will enrol 600 adult patients intubated for ≤ 24 h at the time of enrolment. Eligible patients will be stratified according to admission diagnosis (180 tetanus, 420 non-tetanus) and site and will be randomised in a 1:1 ratio to receive either (1) automated, continuous control of endotracheal cuff pressure or (2) intermittent measurement and control of endotracheal cuff pressure using a manual cuff pressure meter. The primary outcome is the occurrence of VARI, defined as either VAP or VAT during the ICU admission up to a maximum of 90 days after randomisation. Patients in both groups who are at risk for VARI will receive a standardised battery of investigations if their treating physician feels a new infection has occurred, the results of which will be used by an endpoint review committee, blinded to the allocated arm and independent of patient care, to determine the primary outcome. All enrolled patients will be followed for mortality and endotracheal tube cuff-related complications at 28 days and 90 days after randomisation. Other secondary outcomes include antibiotic use; days ventilated, in ICU and in hospital; inpatient mortality; costs of antibiotics in ICU; duration of ICU stay; and duration of hospital stay.

Discussion: This study will provide high-quality evidence concerning the use of continuous endotracheal cuff pressure control as a method to reduce VARI, antibiotic use and hospitalisation costs and to shorten stay.

Trial registration: ClinicalTrials.gov, NCT02966392 . Registered on November 9, 2016. Protocol version: 2.0; issue date March 3, 2017.

Keywords: Hospital-acquired infection; Intensive care unit; Intubation; Tracheal tube cuff pressure; Ventilator-associated pneumonia.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained through the Oxford Tropical Research Ethics Committee (OxTREC) (reference 26-16), the Tropical Diseases Hospital in Ho Chi Minh City (reference number 32/HDDD), Trung Vuong Emergency Hospital (reference number 670/BVTV) and National Hospital of Tropical Diseases (reference number 22/HDDD-NDTU). The original approved version of this study did not have a 90-day limit on the intervention and follow-up for endpoints; these changes have been approved in amendments. Patients who require intubation at the study site on or after arrival or who have been intubated prior to transfer, or their legal representatives, will be approached as soon as is possible in line with prioritising patient care, fully informed, and invited to consent to the study. Consent will be obtained by study or hospital staff trained in good clinical practice and the consent procedure. Patients will be enrolled only after informed consent has been obtained. Randomisation will then take place, and patients will be managed in the appropriate manner. Patient care will never be delayed for consent or randomisation procedures. Where consent is provided by a patient’s representative and they later regain the capacity to provide consent, the patient will be approached and given the opportunity to withdraw from the study.

Consent for publication

Not applicable.

Competing interests

DW has served as a board member for Astellas; lectured for HealthCare 21, Astellas, Pfizer, Sage, Johnson & Johnson, and Bioproducts; received support for the development of educational presentations from Astellas; and received funding from Pfizer (board member) and Astellas (board member), as well as Sage, Healthcare21, Johnson & Johnson and Bioproducts speaker bureaus (all unrelated to this work). The other authors declare that they have no competing interests.

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Figures

Fig. 1

Flowchart of study procedures

Fig. 2

Schedule of enrolment, interventions and assessments. HAI Hospital-acquired infection, ICU Intensive care unit, APACHE Acute Physiology and Chronic Health Evaluation, PEEP Positive end-expiratory pressure, FiO2 Fraction of inspired oxygen, HbA1c Glycated haemoglobin, VARI Ventilator-associated respiratory infection, PPI Proton pump inhibitor