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CTRI Number  CTRI/2018/12/016489 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 30/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening 
Study Design  Other 
Public Title of Study   To analyse changes in optic nerve sheath diameter in with various levels of end tidal carbon dioxide. 
Scientific Title of Study   Optic nerve sheath diameter response to end tidal carbon dioxide variation with ultrasonography in patients under general anaesthesia. 
Trial Acronym  ONSD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aman Malawat 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Medical College and Hospital, Jaipur 
Address  c/o Dr Durga Jethava Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7737200883  
Fax    
Email  dr.a.malawat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Durga Jethava 
Designation  PHOD Department Of Anaesthesiology 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur 302022

Jaipur
RAJASTHAN
302022
India 
Phone  9414452382  
Fax    
Email  djethava@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aman Malawat 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Medical College and Hospital, Jaipur 
Address  c/o Dr Durga Jethava Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7737200883  
Fax    
Email  dr.a.malawat@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Hospital, Jaipur 
 
Primary Sponsor  
Name  Dr Aman Malawat 
Address  c/o Dr Durga Jethava Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur 302022 Rajasthan 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Durga Jethava  PHOD Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur 302022 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aman Malawat  Mahatma Gandhi Medical College and Hospital  Department Of Anaesthesiology RIICO Institutional Area, Sitapura, Jaipur 302022
Jaipur
RAJASTHAN 
7737200883

dr.a.malawat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Optic Nerve Sheath Diameter at EtCO2 30 mmHG  Sonographic measurement of optic nerve sheath diameter at 1 min and 5 min interval at EtCO2 30 mmHg 
Comparator Agent  Optic Nerve Sheath Diameter at EtCO2 40 mmHg  Sonographic measurement of optic nerve sheath diameter at 1 min and 5 min interval at EtCO2 40 mmHg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient with ASA CLASS I/ II
Patient aged 18-70 years
Patients scheduled for laproscopic cholecystectomy under general anesthesia
Patient’s written and informed consent
 
 
ExclusionCriteria 
Details  Patient with ASA CLASS III, IV & V
Patients with a history of head injury, any respiratory or cardiovascular system disease.
Non consenting patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Optic nerve sheath diameter at various levels of EtCO2  • Optic nerve sheath diameter with EtCO2 30 mmHg at 1 minute
• Optic nerve sheath diameter with EtCO2 30 mmHg at 5 minutes
• Optic nerve sheath diameter with EtCo2 40 mmHg at 1 minute
• Optic nerve sheath diameter with EtCo2 40 mmHg at 5 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
Mean arterial pressure (MAP), heart rate, body temperature   1 MIN and 5 min at EtCO2 30 mmHg and EtCO2 40 mmHg respectively 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/12/2018 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Intracranial Pressure monitoring is a crucial component of neuro-critical patient management. Clinical signs of increased intra cranial pressure can be very dubious and can be seen as a delayed cerebral decompensation. Monitoring of intracranial pressure can be invasive and non invasive. Out of which invasive techniques have advantage of reflecting real time intracranial pressures but are associated with certain complications like, infections, intracranial bleeding, occlusion of the catheter tip by blood, debris and difficulty in locating ventricle in presence of cerebral oedema. It is due to these disadvantages of invasive methods that non-invasive methods despite not being as accurate as invasive ones in predicting real time value have upper hand over the former method of intracranial pressure monitoring.

 

Non invasive techniques such as computerised tomographic scan or Magnetic resonance imaging are excellent tools to measure raised intra cranial pressure nowadays but ,since these techniques are time consuming, requires trained and skilled personnels and may require transportation of patients who may be unstable; Ultrasound being quick, economic and bed side procedure is rapidly becoming popular for identifying raised ICP in intensive and critical care units by monitoring optic nerve sheath diameter. Also, Ultrasonography is advantageous than clinical assessment as it helps diagnosing raised ICP, even in patients under sedation or with altered sensorium.

Rapid evaluation and management of ICP can be helpful in early detection of increased ICP and improve postoperative outcomes in neurocritically-ill patients. Ultrasonography of optic nerve sheath diameter (ONSD) is a non-invasive, indirect technique of evaluating changes in ICP and it shows a good correlation with direct ICP measurement. ONSD is well responsive to ICP change [12], despite of the association between ONSD and PaCO2, the dynamic responsiveness of ONSD, in asso­ciation with acute arterial CO2 change which can affect ICP, still has not been well investigated.

 

In the present study, we have hypothesized that the sonographic ONSD, as a surrogate for the ICP, can rapidly change in response to arterial CO2 change by monitoring ETCO2 reduction using short-term hyperventilation. To investigate the rapid change of ONSD, we monitor ETCO2, instead of PaCO2, to adjust systemic CO2 level constantly throughout the research. For the evaluation of acute response of ONSD, we measured ONSD in a continu­ous fashion on a single fixed transverse sonographic plane.

 
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