Heart Attack Clinical Trials

Find Heart Attack Clinical Trials Near You

Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Aims: * To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients. * To develop a sedation protocol for ECMO patients with input from patients, their family, and staff. Design/methods: Study 1: The investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2. Study 2: The investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group. Patient and public involvement/engagement: The investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public. Impact/dissemination: The investigators will share findings through social media, patient charities, research papers and conferences.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Aged 18 years and older.

• Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and/or propofol).

• Receiving ECMO for moderate to severe respiratory failure (PaO2/FiO2 (P/F) ratio \<20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.

• Non-ECMO ICU patients (control group): must satisfy inclusion criteria 1 and 2, and have received mechanical ventilation for moderate to severe respiratory failure (P/F ratio \< 20kPa) for at least 48 hours OR mechanical ventilation for cardiovascular disorder (out of hospital cardiac arrest, following cardiothoracic or transplant surgery or percutaneous coronary intervention or acute heart failure).

• Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).

• ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.

• Family members of ECMO survivors, whose relative is no longer hospitalised.

Locations
Other Locations
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Christopher Remmington, MPharm
christopher.remmington@nhs.net
+442078365454
Backup
Louise Rose, PhD
louise.rose@kcl.ac.uk
+4478365454
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 120
Treatments
ECMO patients
Mechanically ventilated adult ICU patients who received ECMO organ support
Healthcare professionals
Doctors, nurses and pharmacists who look after ECMO patients
Non-ECMO
Mechanically ventilated adult ICU patients who did not receive ECMO organ support
ECMO survivors and family
ECMO survivors who have recovered and discharged from hospital. Family of ECMO survivors.
Related Therapeutic Areas
Sponsors
Leads: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov

Similar Clinical Trials