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CTRI Number  CTRI/2024/05/066916 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Clinical Profile and Outcome of Pulmonary Disease in patients admitted in Respiratory Intensive Care Unit 
Scientific Title of Study   Clinical Profile and Outcome of Pulmonary Disease in patients admitted in Respiratory Intensive Care Unit- a cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kishan Prakash Rai 
Designation  Junior Resident M.D Respiratory Medicine 
Affiliation  Rohilkhand Medical College 
Address  DEPARTMENT OF RESPIRATORY MEDICINE,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILIBHIT BYPASS ROAD,BARIELLY

Bareilly
UTTAR PRADESH
243006
India 
Phone  9740669242  
Fax    
Email  kishanprai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Javed Khan 
Designation  Associate Professor 
Affiliation  Rohilkhand Medical College 
Address  DEPARTMENT OF RESPIRATORY MEDICINE,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILBHIT BYPASS ROAD,BARIELLY

Bareilly
UTTAR PRADESH
243006
India 
Phone  8755147786  
Fax    
Email  javedpulmonarymedicine@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Javed Khan 
Designation  Associate Professor 
Affiliation  Rohilkhand Medical College 
Address  DEPARTMENT OF RESPIRATORY MEDICINE,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILBHIT BYPASS ROAD,BARIELLY

Bareilly
UTTAR PRADESH
243006
India 
Phone  8755147786  
Fax    
Email  javedpulmonarymedicine@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital 
Address  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILBHIT BYPASS ROAD,SURESH SHARMA NAGAR,BARIELLY 
Type of Sponsor  Private medical college 
 
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 Kishan Prakash Rai  Rohilkhand Medical College and Hospital  Room no- 1090/6, Respiratory Intensive Care Unit, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH 
9740669242

kishanprai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Rohilkand Medical College & Hospital Bareilly  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients who fulfil the following criteria will be included:
1.Patients willing to give informed consent.
2.All the patients admitted in RICU
 
 
ExclusionCriteria 
Details  The group of patients excluded from the study include those:
1.Patients not willing to participate in the study.
2.Patients of HIV positive status
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the pattern of pulmonary disease and outcome of patients admitted in RICU at tertiary care centre.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To Study the Patients clinical profile admitted in RICU.
2. To assess the outcome of patient staying in RICU with various pulmonary diseases.
3. To determine pattern of pulmonary disease commonly seen in RICU. 
one year 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   15/05/2024 
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 Applicable 
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  

Respiratory intensive care unit is an area within hospital which is well equipped and under control of specialised team of doctors, nurses and paramedical staff for providing all possible health facilities to the patient.

It is also a specialized place for the monitoring and treatment of patients with acute respiratory failure due to any cause and of patient with acute or chronic respiratory failure. Thus, these patients are a heterogeneous

group with severe illnesses, with or without multiple system dysfunction / failure and multiple coexisting medical problems1.

 

 It is well accepted that early and appropriate referral of patients to an intensive care unit can significantly reduce early and possible late mortality in critically ill patients. At the same time improper selection of patients for intensive care unit, who block ICU beds often limits bed availability in ICUs and may adversely affect the dynamics of the hospital1.

The common diseases with which a patients is admitted in RICU are:

1.     Acute Exacerbation of COPD

2.     Pneumonia: - Hospital acquired pneumonia is the second most common nosocomial infection in intensive care unit. HAP is the most common cause of mortality which ranges from 30 to 70%. Incidence of HAP is higher in ICU acquired respiratory infection4

3.     BRONCHECTIASIS

4.     PNEUMOTHORAX

5.     BRONCHIAL ASTHMA(AE)

Critically ill patients are responsible for 10–20% of global hospital costs and the ability to identify critically ill patients who will not survive until hospital discharge may allow identification of high risk patients 2

 Patients inside respiratory Intensive Care Unit  A Clinician has to consider many inter-related factors in making a prognosis regarding outcome in critically ill patients, including age, severity and irreversibility of the acute illness, physiological reserve, associated co morbidity and response to therapy.

This study will be conducted to find out the clinical profile, intervention given and final outcome of patients admitted in our respiratory icu which may help us to form a management guideline for better treatment of patients.

 
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