Mucoactives in Acute Respiratory Failure

• Research type

  Research Study

• Full title

  Mucoactive drugs for acute respiratory failure: A 2x2 factorial, randomised, controlled, open-label, Phase 3, pragmatic, clinical and cost effectiveness trial with internal pilot

• IRAS ID

  293630

• Contact name

  Danny McAuley

• Contact email

  d.f.mcauley@qub.ac.uk

• Sponsor organisation

  Belfast Health and Social Care Trust

• Eudract number

  2021-003763-94

• Duration of Study in the UK

  4 years, 3 months, 1 days

• Research 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: Usual airway clearance management (suctioning, heated humidification, and respiratory physiotherapy) plus carbocisteine
  Group 2: Usual airway clearance management plus hypertonic saline
  Group 3: Usual airway clearance management plus carbocisteine and hypertonic saline
  Group 4: Usual airway clearance management

  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.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  21/YH/0234

• Date of REC Opinion

  15 Oct 2021

• REC opinion

  Favourable Opinion