| CTRI Number |
CTRI/2021/03/031713 [Registered on: 04/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Pain assessment in mechanically ventilated patients in intensive care units |
|
Scientific Title of Study
|
Pain assessment in mechanically ventilated patients in intensive care units: A prospective observational comparitive study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAFDHAR HASMI R |
| Designation |
Post graduate student |
| Affiliation |
King george medical university |
| Address |
Department of anaesthesia
King george medical university
Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9443747318 |
| Fax |
|
| Email |
safdharlorzi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MANISH KUMAR SINGH |
| Designation |
Assistant professor |
| Affiliation |
King george medical university |
| Address |
Department of anaesthesia
King george medical university
Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9453625852 |
| Fax |
|
| Email |
manish.is.singh34@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MANISH KUMAR SINGH |
| Designation |
Assistant professor |
| Affiliation |
King george medical university |
| Address |
Department of anaesthesia
King george medical university
Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9453625852 |
| Fax |
|
| Email |
manish.is.singh34@gmail.com |
|
|
Source of Monetary or Material Support
|
| king george medical university, lucknow |
|
|
Primary Sponsor
|
| Name |
king georgemedical university |
| Address |
king george medical university,
chowk,
lucknow,
uttarpradesh, india |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish kumar singh |
King george medical university |
Department of anaesthesia,
King george medical university
Chowk,Lucknow, Uttar Pradesh
Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH |
9453625852
manish.is.singh34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King george medical university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Critically ill patients >18years of either sex
2. Mechanically ventilated patients in ICU with >24hours stay |
|
| ExclusionCriteria |
| Details |
1. Patient extubated within 24 hours of admission
2. Patients on muscle relaxants and chronic analgesic therapy
3. Patients with previous history of psychiatric illness, neuropathy, quadriplegia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of critical care pain observational tool quality among mechanically ventilated patients in medical surgical intensive care units |
The study will be assessed after one year approx |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of critical care pain observational tool quality among mechanically ventilated patients in medical surgical intensive care units |
Patient will be assesed until the patient get discharged or transfered from the intensive care units where the study is conducted |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective observational comparative study to assess the pain in mechanically ventilated patients in intensive care units.
The aim of this study is to evaluate the effectiveness of critical care pain observational tool quality among mechanically ventilated patients in medical surgical intensive care units. |