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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvenkat94@gmail.com].
- 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.
- 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. |