Skip to main content
Clinical Trials/CTRI/2025/11/096847
CTRI/2025/11/096847
Not yet recruiting
Phase 2

A Randomised Controlled Trial on Non-Pharmacological versus Pharmacological Interventions for Prevention of Delirium among Critically ill patients.

Apollo Speciality Hospital1 site in 1 country40 target enrollmentStarted: November 15, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Apollo Speciality Hospital
Enrollment
40
Locations
1
Primary Endpoint
1.Comparing the effectiveness of Non-pharmacological versus pharmacological interventions for prevention of delirium among critically ill patients

Overview

Brief Summary

Delirium is a common phenomenon  occuring in 20-70% of hospitalized patients.Majoring of patients undergoing surgery and recurrent admissions due to chronic illness, polypharmacy and financial constraints cause lot distress to patients and family as well and are more for delirium  which in turn cause more morbidities and mortality .Hence Prevention and early detection are crucial.All previous studies have reported the incidence and various methods for management of delirium ,there is a paucity of literature comparing these two potentially effective techniques for Delirium prevention. Hence we are planning to conduct this RCT in out tertiary care centre to compare the effectiveness of Nonpharmacological techniques versus pharmacological interventions for prevention of delirium among critically ill patients. This study will lead pathway for major studies on Delirium background

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.minimum length of stay more than 24hrs 2.Awake intubated patients.

Exclusion Criteria

  • Poor GCS ,Prior Dementia and cognitive impairement
  • already diagnosed encephalopathy 3.Not coopertive.

Outcomes

Primary Outcomes

1.Comparing the effectiveness of Non-pharmacological versus pharmacological interventions for prevention of delirium among critically ill patients

Time Frame: 1.During ICU Stay- 0,24hrs,48hrs,72hrs and | 2. During discharge from ICU

2. To Estimate the frequency of occurence of Delirium in ICU

Time Frame: 1.During ICU Stay- 0,24hrs,48hrs,72hrs and | 2. During discharge from ICU

Secondary Outcomes

  • Duration of Mechanical ventilation(length of stay in ICU & Hospital stay)

Investigators

Sponsor
Apollo Speciality Hospital
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Vanitha N

APOLLO SPECIALITY HOSPITAL

Study Sites (1)

Loading locations...

Similar Trials