| CTRI Number |
CTRI/2017/11/010499 [Registered on: 15/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of oxygen on management of patients having brain surgery |
|
Scientific Title of Study
|
“Effect of different inhaled oxygen concentration on PaCO2-EtCO2 gradient in neurosurgical patients. †|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
neha magoon |
| Designation |
2nd year resident MD Anaesthesia |
| Affiliation |
LTMMC,sion.Mumbai |
| Address |
Department of anaesthesia, college building,4th floor. Lokmanya tilak municipal medical college and hospital, sion. Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7045704151 |
| Fax |
|
| Email |
neha_magoon@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangi S Karnik |
| Designation |
Professor |
| Affiliation |
LTMMC,sion.Mumbai |
| Address |
Dept. of Anaesthesia,
Lokmanya Tilak municipal medical college,
sion.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemangi S Karnik |
| Designation |
Professor |
| Affiliation |
LTMMC,sion.Mumbai |
| Address |
Dept. of Anaesthesia,
Lokmanya Tilak municipal medical college,
sion.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Neurosurgery OT,lokmanya tilak municipal medical college and hospital.sion.Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
Dr Hemangi S karnik |
| Address |
Dept. of anaesthesia.
lokmanya tilak medical college and government hospital,sion.mumbai |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 |
| Neha Magoon |
Lokmanya tilak municipal medical college and hospital |
Neurosurgery OT, 3rd floor, above ward 8. LTMGH,sion.
Mumbai
MAHARASHTRA |
7045704151
neha_magoon@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra University Of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
neurosurgical patients, (1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing neurosurgical procedures in supine or supine with head up position.
2) Patients needing invasive arterial access during surgery. |
|
| ExclusionCriteria |
| Details |
1) Patients with impaired pulmonary gas exchange (baseline hypercarbia,hypoxia).
2) Patients with dependence on oxygen supplementation or CPAP.
3) Patients with bronchial asthma/COPD.
4) Patients with chest trauma/ chest drain in situ.
5) Operated pneumonectomy or lobectomy in past.
6) Patients with abdominal distension /pregnancy/ascites/any other cause affecting breathing.
7) Any contraindication for nitrous oxide.
8) Patients requiring frequent changes in ventilatory strategies.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain if PaCO2_EtCO2 gradient changes with varying FiO2 concentration. |
August 2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find correlation between FiO2 % and PaCO2-EtCO2 gradient,if any. |
June 2017 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2016 |
| Date of Study Completion (India) |
31/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
End tidal CO2 values are routinely used to monitor adequacy of ventilation.In neuroanaesthesia practice, continuous assessment of ventilation and control of PaCO2 is essential for adjusting intracranial pressure as well as cerebral perfusion. The value of EtCO2 depends on extra pulmonary and pulmonary factors.In baseline conditions,the gradient between PaCO2 and EtCO2 range between 3-5 mmHg.Determinants of this gradient are multifactorial and magnitude of their effect is often unpredictable.Larson and Severinghans reported that the administration of O2 to awake sitting subjects led to an increase in PaCO2-EtCO2 gradient.They attributed this finding to the vasodilatory effect of O2 on blood vessels at the base of lung. The current study was undertaken to assess the effect of varying levels of inspired oxygen fraction on difference between arterial carbon dioxide levels and exhaled CO2 levels in patients undergoing neurosurgery. |