EFFICACY OF ABCDEF BUNDLE (assess, prevent and manage pain, both spontaneous awakening and breathing trial, choice of analgesia and sedation, assess, prevent and manage delirium, early mobility and exercise, and family engagement and empowerment) FOR REDUCTION OF INTENSIVE CARE DELIRIUM IN ADULT EMERGENCY MEDICAL PATIENTS ADMITTED WITH SEPSIS

This study will be carried out at the Emergency Medical Ward-22, Emergency department, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. The ABCDEF bundle will be used in daily care in this hospital’s 12 bed ICU, Emergency medical ward-22. The study population will comprise any adult (18-year or older) patients admitted to the hospital’s medical ICU with a diagnosis of sepsis or septic shock, independent of mechanical ventilator status. The pre-bundle (control) implementation group will have 30 patients, and the post-bundle (intervention) implementation group will have another 30 patients. Convenience sampling will be done. And for those who are eligible, proxy informed consent will be obtained from primary care taker, after omitting exclusion and will be taken for study. A registered nurse, junior resident on duty, and the lead investigator (junior resident) will be included in the process evaluation research team.In the first 6 months, 30 patients will be enrolled in the trial as a control group. They will be assessed for sepsis using the Sequential Organ Failure Assessment (SOFA) scoring tool.

Baseline SOFA score will be assumed to be zero in patients not known to have any pre-existing organ dysfunction and those with a score of 2 or above will be considered to have sepsis and eligible for study. In patients with pre-existing organ dysfunction, there should be acute change in total SOFA score by ≥ 2 points consequent to infection to be eligible. A patient will be considered to have an infection if the treating physician stated infection in the medical record or started antibiotics or there are serological (immunoglobulin titres) and/or microbiological evidence (body fluids positive for microbes with staining techniques or cultures) of infection. Patient meeting the criteria for sepsis with persisting hypotension requiring vasopressors to maintain MAP≥ 65 mmHg and having a serum lactate level >2 mmol/l (18mg/dl) despite adequate fluid resuscitation will be considered to be in septic shock.

Those who meet the inclusion and exclusion criteria, will be included in the study. Participants in this group will receive conventional (standard) ICU care with standard sepsis management algorithms and will be monitored for 14 days in the ICU or until discharged, death, or transfer to general ward or other departments, whichever occurs first. The junior resident (principal investigator) will keep the observation on pain management, SAT and SBT trials conducted on patients, assessment and management of delirium, degree of mobilization and the family engagement regarding the patients in this group but no intervention will be applied upon. If any subject develops delirium during their hospital stay, the duration of the delirium, antipsychotic dosages required, and length of ICU stay will all be noted. However, all decisions regarding the management of the patient will be made completely by the treating physician and in accordance with conventional ICU care, with no active intervention being used on this control group.

In the next 1 month, the residents and staffs on duty will be trained on implementing the ABCDEF bundle in ICU patients on a weekly basis for 4 consecutive weeks before implementation of the ABCDEF bundle.

Then another 30 patients will be enrolled in the same manner as before over the next 6 months. They will first be assessed for the presence of sepsis using the SOFA score, and if score of 2 or more achieved, with inclusion and exclusion criteria satisfied, they will be recruited in the trial. However, in this group, the ABCDEF bundle will be used from the start (within 24 hours after admission). Participants in this group will also be monitored for 14 days in the ICU or until discharged, death, or transfer to general ward or other departments, whichever occurs first.

Finally, the outcomes in the two groups will be analyzed to assess efficacy of the ABCDEF bundle in reducing intensive care delirium.