Study area:

Department of Critical Care Medicine, Sir Ganga Ram Hospital, New Delhi, India

Study design: Prospective cohort study

Study duration:

After the date of approval from the hospital research and ethics committee, enrollment will be done till December 2023 and followed up till March 2024

Study population:

Mechanically ventilated patients admitted to ICU and being considered for weaning

Inclusion Criteria

1.    Age 18-80 years of both sexes

2.    Richmond Agitation-Sedation Scale scores �’3 and above

Exclusion Criteria

1.   Patients who experienced cardiac arrest

2.    Patients who had a traumatic brain injury

3.     Patients receiving neuromuscular blockers

4.     Infusions of propofol, ketamine, and dexmedetomidine

5.        Failure to obtain consent

Primary outcome measures

Patients who are diagnosed to have delirium and risk factors associated with it.

Risk factors

Data will be collected in a predefined study proforma developed for the study and the following risk factors would be evaluated

1.        Age

Comorbidities

2.       History of coronary artery disease

3.     History of neurological conditions including dementia

4.   History of chronic kidney disease

Iatrogenic factors

5.   Cumulative dose of opioids

6.     Cumulative dose of benzodiazepines

7.      Cumulative dose of anticholinergic drugs

8.       Cumulative dose of antipsychotic drugs

Secondary outcome measures

Grouping variable

Patients diagnosed to have delirium or no delirium during the course of ICU stay

Outcome variables

1.    28-day hospital mortality

2.        Cumulative days of invasive mechanical ventilation

3.       Length of stay in the ICU

4.       Hospital length of stay

5.       Need for home care services after hospital discharge in terms of

1.   Oxygen requirement

2.   Use of nurse attendant

3.   Tracheostomy/ line care/ feed requirement (nasogastric tube)

4.   Ambulation

5.  Ability to do normal daily activities such as going to the washroom/ wearing clothes/ using the toilet etc.

Methodology

All patients admitted to the ICU and on mechanical ventilation for more than 48 hours will be screened for enrolment. The decision to wean the patients from mechanical ventilation will be at the discretion of the clinical team. Readiness for extubation will be assessed daily using standardized criteria. If all criteria were met, a T-piece breathing trial will be initiated. The first screening for delirium will be done by the resident doctor at this time, after confirming the RAAS score and will be conducted daily. The sedation scale used in the study is the Richmond Agitation Sedation Scale (RASS), which is a 10-point scale ranging from + 4 to - 5, with a RASS score of 0 denoting a calm and alert patient. with more negative scores indicating deeper sedation and more positive scores indicating increasing agitation. For the purpose of this study, Coma is defined as a RASS score of - 4 or - 5, in which case the CAM-ICU is not assessed. Normal is defined as RASS scores - 3 and above when the assessment of delirium is permitted using the CAM-ICU.

Assessment of primary outcomes

The risk factors for delirium will be noted in the patients.

1.    Age of the patients would be noted as per the official data during admission

2.       History of comorbidities (presence of coronary artery disease, neurological disorders including dementia, chronic kidney disease) would be noted based on the previous medical records and history given by the patient’s attendant

3.       The cumulative dosage and duration of use of opioids, benzodiazepines, anticholinergics and antipsychotics during the ICU stay will be noted from the nurse’s chart from the date of initiation till termination as per standard units of the drug

Assessment of secondary outcomes

1.       The patients would be followed up till hospital discharge or death whichever is earlier

2.       The ICU and hospital length of stay will be recorded in days starting from admission till discharge/death

3.       The duration, the patient was on invasive mechanical ventilation will be recorded in days, from the date to initiation of invasive mechanical ventilation till extubation

4.      The discharged patient will be followed up after discharge for a maximum period of one month and the following parameters will be recorded

1.   Oxygen requirement

2.   Use of nurse attendant

3.   Tracheostomy/ line care/ feed requirement (nasogastric tube)

4.   Ambulation

5.   Ability to do normal daily activities such as going to the washroom/ wearing clothes/ using the toilet etc.

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