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MARCH Participant Information


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)
Group 2: Hypertonic Saline plus Usual airway clearance management
Group 3: Carbocisteine and hypertonic saline plus Usual airway clearance management
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.

 
Document Version
Personal Legal Representative (PerLR) Participant Information Sheet/Consent Form MARCH PerLR_PISCF_v2.0_Final_25102021
Professional Legal Representative (ProfLR) Participant Information Sheet/Consent Form MARCH ProfLR_PISCF_v2.0 Final 25102021
Consent to Continue Participant Information Sheet/Consent Form MARCH Consent to Continue_PISCF_v2.0 FINAL_25102021
Personal Legal Representative (PerLR) Contact Form MARCH PerLR_Contact Form_v1.0 Final_31082021
Personal Legal Representative (PerLR) Telephone Agreement Form MARCH PerLR_Telephone Agreement Form_v1.0 Final_31082021
GP Letter MARCH_GP Letter_v1.0 Final_31082021
Relative’s Room Poster 2023_02_10_MARCH_Relatives’ Room Poster_v1.0 Final