| 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
|
|
|
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 assoÂciation 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 continuÂous fashion on a single fixed transverse sonographic plane. |