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CTRI Number  CTRI/2023/05/052669 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 20/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To find relationship between oxygen level and death after surgery in cancer patients. 
Scientific Title of Study   "Correlation of Peripheral Perfusion Index with peri operative morbidity and mortality in oncological patient undergoing General Anaesthesia: An observational 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 Sarthak Misra  
Designation  MD trainee 
Affiliation  Indira Gandhi institute of medical sciences 
Address  Department of anaesthesiology and ccm 1st floor ward block, Igims

Patna
BIHAR
800014
India 
Phone  8210641979  
Fax    
Email  drsarthakmisra2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bibha Kumari 
Designation  Associate Professor 
Affiliation  Indira Gandhi institute of medical sciences 
Address  Department of Anaesthesiology and ccm 1st floor, Igims

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarthak Misra  
Designation  Junior Resident ( first year) 
Affiliation  Indira Gandhi institute of medical sciences 
Address  Department of Anaesthesiolgy and ccm, 1st floor, Igims

Patna
BIHAR
800014
India 
Phone  8210641979  
Fax    
Email  drsarthakmisra2021@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi institute of medical sciences Sheikhpura Patna  
 
Primary Sponsor  
Name  Dr Sarthak Misra  
Address  Indira Gandhi institute of medical sciences Sheikhpura Patna  
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 Sarthak Misra   Indira Gandhi institute of medical sciences   State cancer institute, Ot 1,2
Patna
BIHAR 		 8210641979

drsarthakmisra2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee, IGIMS,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate.
2.Patients > 18 years of age.
3.Patients with no limb deformities.
4.ASA grade 1-4 patients.
5.Operative procedure requiring General Anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patients refusal to participate.
2.Patients age <18 years of age.
3.Any contraindications to General Anaesthesia.
4.Patients with limb deformities, amputated limbs, gangrene, PVD.
5.ASA grade 5 and above.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association between perioperative PPI with postoperative morbidity and mortality after first 36 hours of stay in ICU.  To evaluate the association between perioperative PPI with postoperative morbidity and mortality after first 36 hours of stay in ICU. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Inra operative hemodynamics(Heart rate, MAP, SBP, DBP)
2. Post operative AKI(S. Creatinine, BUN)
3. Post operative need of Analgesia. 		 1 year 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/05/2023 
Date of Study Completion (India) 20/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil  
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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsarthakmisra2021@gmail.com].

  6. For how long will this data be available start date provided 15-05-2024 and end date provided 30-04-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The peripheral perfusion index (PPI), derived from the photoelectric plethysmography pulse oximetry signal, decreases in response to hypoperfusion reflecting the ratio between the pulsatile and non-pulsatile component of the arterial waveform in the tissue. Thus, changes in peripheral perfusion, both from reduced Cardiac Output and sympathetically mediated peripheral vasoconstriction to augment central blood volume, are reflected in PPI. Reduced peripheral perfusion has been associated with both morbidity and mortality in critically ill patients, patients with septic shock, and after acute or major elective surgery. 
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