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CTRI Number  CTRI/2024/01/062045 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 14/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized Factorial Trial 
Public Title of Study   It is to analyse noise level in Neurosurgical Operation Theatre and its Effects on Anaesthesia Residents  
Scientific Title of Study   “Analysis of Noise Levels in Neurosurgical Operation Theatre and Its Effects on Anaesthesia Residents:An Observational Cohort 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 Renu Bala  
Designation  Professor  
Affiliation  Pt. B D Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Pt.BD Sharma Rohtak ,Haryana 124001 , India ,2 Floor Modular OT complex

Rohtak
HARYANA
124001
India 
Phone  8901322251  
Fax    
Email  neurodmrenu@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti 
Designation  Junior Resident  
Affiliation  Pt. B D Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care ,Pt.BD Sharma Rohtak Haryana 124001 ,India,2 Floor Modular OT complex

Rohtak
HARYANA
124001
India 
Phone  7302757672  
Fax    
Email  jyotibhatia885@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti 
Designation  Junior Resident  
Affiliation  Pt. B D Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care PT.BD Sharma Rohtak Haryana 124001 ,India 2 Floor Modular OT complex HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  7302757672  
Fax    
Email  jyotibhatia885@gmail.com  
 
Source of Monetary or Material Support  
Institutional Pt. BD Sharma PGIMS Rohtak 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical Care 
Address  Pt. B D Sharma University of Health Sciences PGIMS Rohtak Haryana 
Type of Sponsor  Government 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 Jyoti  Pt B. D Sharma PGIMS Rohtak  Dept of Anaesthesiology and Critical Care.Pt. BD Sharma Rohtak ,Neurosurgery OT, Lala sham Lal building. HARYANA
Rohtak
HARYANA 		 7302757672

jyotibhatia885@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers(Anaesthesia Resident) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  All elective neurosurgical OT’s of duration more than three hours 
 
ExclusionCriteria 
Details  1. All elective neurosurgical OTs of duration less than three hours.
2. Presence of background music. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the level of noise (in dB) using Sound Level Meter in neurosurgical operation theatre.  To measure the level of noise (in dB) using Sound Level Meter in neurosurgical operation theatre for duration 6 hours from the starting of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To see the effect of noise pollution on health care workers   Every 15 minutes  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   21/02/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jyotibhatia885@gmail.com].

  6. For how long will this data be available start date provided 21-11-2024 and end date provided 21-12-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is purely an observational study. The neurosurgical operating room will be visited 15 minutes before the schedule time of the start of surgery for equipment placement and baselines readings. Noise will be measured by digital Sound Level Meter (SLM100). This instrument (SLM) will be calibrated and placed on a tripod, at a distance of 0.5 feet from the wall, at a height of 5 feet and at a distance of minimum 6 feet from noise emitting devices such as monitors, cautery, and suction machines etc. The baseline readings will be taken inside neurosurgical operation theater 15 minutes before the patient is shifted to the OT There will be continuous monitoring of sound levels during 6 hours’ time period and sound level recording will be done every 15 minutes. During each measurement following observations will be recorded in a standard proforma.
i) Number of persons in OT including surgeon, anaesthesia team, nursing staff or bearers.
ii) Equipment functional at that time such as cautery, suction machine, drill machines, alarms etc.
iii) Phases of anaesthesia:
a) Induction-which will start from holding face mask till successful intubation.
b) Reversal-switching off anaesthetic agents till extubation.
iv) Phases of surgery:
a) Phase 1- will start from skin incision to bone flap removal and laminectomy, in cranial surgery and spine surgery respectively.
b) Phase 2- will start from end of stage1 till skin closure.
In surgeries such as cranioplasty, ventriculoperitoneal shunt, endoscopic surgery the entire surgery will be recorded in phase 2.
v) Others- If there is any miscellaneous source of noise such as conversations,
 
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