Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on improving how sedation (medicine to relieve pain and help patients relax or sleep) is given to very sick adults who need a life support machine called ECMO. ECMO helps people with severe heart or lung problems by doing the work of their heart and lungs temporarily. While ECMO can save lives, patients who survive often face long-term issues like anxiety, memory problems, and trouble moving around. These problems might be linked to how much sedation they receive during treatment. The trial aims to better understand current sedation practices for ECMO patients, compare them with those used for other critically ill patients, and develop a new sedation guide (called a protocol) with input from patients, their families, and healthcare staff. This guide will help doctors and nurses give the right amount of sedation—enough to keep patients comfortable but not so much that it causes extra problems.

Adults aged 18 or older who are very ill and receiving sedation while on ECMO or mechanical ventilation for severe breathing or heart problems in intensive care units in the UK may be part of the first part of the study. In the second part, healthcare workers at two hospitals, along with ECMO survivors who have recovered at home and their family members, will work together to create and review the new sedation guide. Participants in the study won’t receive experimental treatment; instead, the researchers will observe and gather information about sedation use and work with people to design a safer, more effective way to manage sedation in these critical situations. The goal is to make sedation safer and improve recovery for future patients on ECMO.

Gender

ALL

Eligibility criteria

• Stage 1 (multi-centre observational study):
• Inclusion Criteria:
• • 1. Aged 18 years and older.
• • 2. Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and/or propofol).
• • 3. Receiving ECMO for moderate to severe respiratory failure (PaO2/FiO2 (P/F) ratio \<20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.
• • 4. 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).
• Exclusion Criteria:
• • 1. Anticipated length of ICU stay in recruiting centre for less than 24 hours.
• • 2. Withdrawal of life-sustaining treatment in the next 24 hours.
• Stage 2 (mixed methods study):
• Inclusion Criteria:
• • 1. 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).
• • 2. ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.
• • 3. Family members of ECMO survivors, whose relative is no longer hospitalised.
• Exclusion Criteria:
• • 1. ECMO survivors currently receiving treatment in hospital.
• • 2. ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).
• • 3. ECMO survivors who cannot communicate in English.
• • 4. Non-ECMO survivors and family members.