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CTRI Number  CTRI/2021/11/038109 [Registered on: 17/11/2021] Trial Registered Prospectively
Last Modified On: 15/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study to compare the effects of Different Positive End Expiratory Pressure on improving oxygenation during Prone Positioning under General Anaesthesia. 
Scientific Title of Study   “Comparison of the Effects of Different Positive End Expiratory Pressure on Respiratory Parameters during Prone Positioning under General Anaesthesia” – A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARAVINDHAN K Y 
Designation  POST GRADUATE 
Affiliation  srm medical college hospital and research centre 
Address  DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
Kancheepuram
TAMIL NADU
603203
India 
Phone  8940068386  
Fax    
Email  kyaravind@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajagopalan venkatraman 
Designation  professor 
Affiliation  srm medical college hospital and research centre 
Address  DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
Kancheepuram
TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajagopalan venkatraman 
Designation  professor 
Affiliation  srm medical college hospital and research centre 
Address  DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
Kancheepuram
TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Source of Monetary or Material Support  
srm institute of science and technology,srm nagar ,potheri,kancheepuram district,tamilnadu 603203 
 
Primary Sponsor  
Name  srm medical college hospital 
Address  DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI,kancheepuram,603203,tamilnadu. 
Type of Sponsor  Research institution and hospital 
 
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 
RAJAGOPALAN VENKATRAMAN  srm medical college hospital and research centre  ROOM NO.1,B BLOCK,DEPARTMENT OF ANESTHESIOLOGY,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM NAGAR ,POTHERI.
Kancheepuram
TAMIL NADU 
9894581455

drvenkat94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
srm medical college and research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PEEP of 0  Applied intraoperatively continuously throughout the surgery 
Intervention  PEEP of 10  Applied intraoperatively continuously throughout the surgery 
Intervention  PEEP of 5  applied continuously intraoperatively throughout the surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patient undergoing elective spine instrumentation surgeries in prone posistion. 
 
ExclusionCriteria 
Details  patient who refuse to participate,pt. with hepatic dysfunction,renal dysfunction,bleeding siorders,lactating mothers.




 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
arterial oxygenation   30 min after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
peak preesure,plateau preesure,mean arterial pressure.
hemodynamic parameters
intraoperative blood loss. 
during the surgery 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   01/12/2021 
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   NA 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 [drvenkat94@gmail.com].

  6. For how long will this data be available start date provided 21-09-2021 and end date provided 20-09-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

     After obtaining the scientific committee and ethical committee clearance, informed consent written in their own language will be obtained from all the patients Included in the study. Study will be done on patients who are posted for elective surgery for spine fixation under prone positioning in SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, KATANKULLATHUR. Study will be   performed as a prospective randomized single-blinded control study in patients undergoing elective Spine instrumentation surgeries in prone position under general anaesthesia.. Patients will be randomized into three groups by computer generated random numbers and kept in a sealed, opaque envelope.

Group A: No PEEP

Group B: PEEP of 5.

Group C: PEEP of 10.

General anaesthesia will be standardized in all the groups. The patients will be premedicated with alprazolam on the night and two hours before surgery. The patients will be monitored with pulse oxymeter, NIBP, ECG and capnography. Glycopyraollate 0.2mg + Ondansetron 4mg IV will be administered. Morphine 0.15mg/kg will be used as the intraoperative analgesic. Propofol 2 mg/kg is the induction agent and vecuronium 0.1mg/kg is used for intubation. Anaesthesia will be maintained with O2: air with sevoflurane. Patient will be ventilated with Pressure Controlled Ventilation (PCV) to achieve a tidal volume of 7 ml/kg. Respiratory rate will be  kept at 12/min. ETCO2 between 36 and 40. The amount of PEEP will be kept according to the group allotted. Three different timelines will be used to monitor the arterial po2, Peak pressure, plateau pressure and mean pressure, dynamic compliance: before induction (T1), 30 min after prone positioning (T2), and arterial po2 will be seen 30 mins after  extubation. Arterial line will be inserted after shifting the patient to OT. ABG will be taken at the three time lines to look for pH, PO2, and PCO2. The Peak pressure, plateau pressure and mean pressure, dynamic compliance will be measured every 15 min intraoperatively. The haemodynamic parameters like HR and MAP will also be measured every 15 min intraoperatively. The total intraoperative blood loss will be calculated at the end of surgery in all three groups. If MAP reduces by more than 20% from baseline, it will be considered as hypotension. Hypotension will be treated initially with crystalloids and ephedrine in increments of 6mg if necessary.

 
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