CTRI

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CTRI Number

CTRI/2024/01/061285 [Registered on: 09/01/2024] Trial Registered Prospectively

Last Modified On:

02/01/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Preventive
Behavioral
Other (Specify) [ear plugs eye mask]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of use of combination of ear plugs, eye mask and a drug called melatonin in icu patients to prevent sleep disturbances and mental disturbances.

Scientific Title of Study

Effect of combination of melatonin with non pharmacological strategies on delirium prevention in ICU- a randomised controlled trial

Trial Acronym

N/A

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr. Ankhitha R S
Designation	Critical care resident
Affiliation	Narayana hrudayalaya Surgical hospital mysore
Address	MICU Department of Critical Care Medicine, Narayana Hrudayalaya Surgical Hospital CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019 CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019 Mysore KARNATAKA 570019 India
Phone	9483595770
Fax
Email	ankhitha.rs@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Naveen S
Designation	Head of the department of ccm
Affiliation	Narayana hrudayalaya Surgical hospital mysore
Address	MICU, department of Critical care medicine, Narayana Hrudayalaya Surgical Hospital, CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019 CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019 Mysore KARNATAKA 570019 India
Phone	9448922780
Fax
Email	naveen.s.dr@narayanahealth.org

Details of Contact Person
Public Query

Name	Dr. Ankhitha R S
Designation	Criticall care resident
Affiliation	Narayana hrudayalaya Surgical hospital mysore
Address	MICU, Department of Critical Care Medicine, Narayana Hrudayalaya Surgical Hospital,CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019 CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019 Mysore KARNATAKA 570019 India
Phone	9483595770
Fax
Email	ankhitha.rs@gmail.com

Source of Monetary or Material Support

Ankhitha R S Resident Critical care medicine CAH1 3rd phase Devanur 2nd stage R S Naidu nagar Mysore 570019

Primary Sponsor

Name	Ankhitha R S
Address	MICU, Department of critical care medicine, Narayana Hrudayalaya Surgical hospital CAH1 3rd phase devanur 2nd stage RS Naidu nagar Mysore 570019
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ankhitha R S	Narayana Hrudayalaya Surgical Hospital	MICU Department of critical care medicine Narayana Hrudayalaya surgical Hospital CAH 1 3rd phase devanur 2nd stage RS Naidunagar Mysore 570019 Mysore KARNATAKA	9483585770 ankhitha.rs@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Narayan Health Academic Ethic Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (3) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (4) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (5) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (6) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (7) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (8) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	routine care	control group minimising interventions at night and turning down noise and light to the minimum at night will be done and will receive routine care like early mobilisation and family engagement and this will be done for 3 consecutive nights
Intervention	tablet melatonin 3mg orally ear plugs eye mask	before sleeping, patients will be made to take tablet melatonin 3mg orally with sips of water at 9pm and ear plugs and eye mask will be placed at 10pm and this will be done for 3 consecutive nights of admission

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1 adults admitted to icu expected to stay for more than 24 hours 2 ability of patients to understand and communicate 3 patients should be enrolled within 24 hours of ICU admission

ExclusionCriteria

Details

invasive ventilation
altered sensorium or psychiatric illness or seizure or sleep apnoea
hearing or vision impairment
pregnancy and breast feeding
nil bh mouth
hepatic impairment or liver transplant
history of substance abuse
severe heart failure or hypotension
hight blood sugar
already on melatonin therapy or drug allergy to melatonin

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
occurrence of delirium in ICU patients 1 incidence of delirium 2 duration of delirium	CAM ICU will be assessed at 8am 2pm and 8pm everyday for 3 consecutive days in both groups

Secondary Outcome

Outcome	TimePoints
indirect markers of delirium severity	need for antipsychotic or sedation or physical restraints or participation in physiotherapy sessions or patient removal of IV lines or catheters shall be assessed daily for 3 consecutive days
sleep quality assessment by Richards Campbell sleep questionnaire	sleep questionnaire shall be answered everyday in the morning at 8am for 3 consecutive days
compliance and comfort of ear plugs and eye mask	ease of use, effectiveness and comfort shall be assessed at 8am for 3 consecutive days
length of stay in icu or hospital and impact on outcome	till discharge from icu or hospital

Target Sample Size

Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

14/01/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Delirium in critically ill patients is a significant problem encountered in the ICU. It can be attributed to various causes including the hostile ICU environment with continuous monitor sounds, alarms and lighting; the lack of continuous presence of family; or the underlying disease condition itself. Preventing the development of delirium in ICU patients may not only reduce the length of ICU stay, but may in turn reduce the length of hospital stay and thus improve outcomes.

Association between sleep and delirium in the ICU has been established by some studies. Promoting sleep through non- pharmacologic means may reduce the incidence of delirium. Melatonin which is a regulator of circadian rhythm is found to be low in critically ill patients and hence may need supplementation.

Use of some non-pharmacological measures like ear plugs and eye mask have shown promising results in some trials while pharmacological measures have been found useful in some others. While both interventions may have certain limitations individually, but as a part of multicomponent strategy, in combination, they can possibly be more effective. Therefore we wish to conduct a randomised trial to study the effect of such a prophylactic bundle of non pharmacological methods and oral melatonin in promoting sleep and to study its ability to prevent or reduce the occurrence of delirium in ICU patients.