|Clinical Area||Critical Care|
|Description||Mucoactives in Acute Respiratory failure: Carbocisteine and Hypertonic saline|
|Status||Open to recruitment (February 2022 to October 2024)|
|Recruitment Start||February 2022|
|Recruitment to date||431 as of 01/03/2023|
|Trial Design||A 2×2 factorial, randomised, controlled, open-label, Phase 3, pragmatic, clinical and cost effectiveness trial with internal pilot, to determine whether mucoactives (carbocisteine and hypertonic saline) in critically ill patients with acute respiratory failure (ARF) reduce duration of mechanical ventilation|
|Study Aim||Aim : To determine whether use of mucoactives in critically ill patients with acute respiratory failure improves outcomes and is cost effective, compared to usual airway clearance management
Objectives : To conduct a large, UK, multi-centre, pragmatic, randomised controlled trial to:
|Chief Investigators||Dr Bronwen Connolly (Queen’s University Belfast)
Professor Danny McAuley (Queen’s University Belfast)
|Sponsor||Belfast Health and Social Care Trust|
|Funder||National Institute for Health Research
Health Technology Assessment Programme; NIHR130454
|Lay Summary||Many patients in intensive care units (ICU) need help to breathe from a breathing machine (ventilator). This condition is known as acute respiratory failure or lung failure. While on a breathing machine, it is difficult for patients to clear secretions (mucus) from the lungs. Breathing becomes harder if secretions are thick and dry. In some cases, the build-up of secretions can result in a lung infection (ventilator-associated pneumonia).
Mucoactive medications (hereafter ‘mucoactives’) are sometimes prescribed to clear thick secretions. ‘Carbocisteine’ and ‘Hypertonic saline’ are two mucoactives commonly used in UK ICUs. One-third of patients on ventilators receive a mucoactive. However, we do not know if these mucoatives help patients with thick secretions.
Our study will investigate whether one, or both mucoactives clear thick secretions and if their use reduces the time patients spend on ventilators. We will look at patient safety, and any differences in patients’ ICU stay. We will follow patients up for 6 months to know their quality of life and treatment costs to the NHS. We will record if patients die. We will share our study results with ICU clinicians, patients and key decision-makers to improve patient care in the future.
The study will recruit 1956 patients from at least 40 ICUs across the UK. Patients on a ventilator for at least 2 days with thick secretions will be allocated to one of four groups by chance.
Group 1: Carbocisteine plus Usual airway clearance management (suctioning, heated humidification, and respiratory physiotherapy)
A large experienced team of health care professionals and researchers lead this study, including former patients and family members. They will ensure the trial runs smoothly, safely, and finishes on time.