CTRI Number |
CTRI/2018/07/014735 [Registered on: 04/07/2018] Trial Registered Prospectively |
Last Modified On: |
03/07/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
observing about knowledge and practice of low flow anaesthesia |
Study Design |
Other |
Public Title of Study
|
low flow anaesthesia practice and knowledge in Indian government teaching hospital |
Scientific Title of Study
|
Knowledge and practice of low flow anaesthesia: A survey and observational study of low flow anesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shyam Charan Meena |
Designation |
Assistant Professor |
Affiliation |
PGIMER, Chandigarh |
Address |
DEPARTMENT OF ANAESTHEHSIA & INTENSIVE CARE, 4TH FLOOR, MAIN OT COMPLEX, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH
Chandigarh CHANDIGARH 160012 India |
Phone |
7891669817 |
Fax |
|
Email |
drshyam.pgi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Shyam Charan Meena |
Designation |
Assistant Professor |
Affiliation |
PGIMER, Chandigarh |
Address |
DEPARTMENT OF ANAESTHEHSIA & INTENSIVE CARE, 4TH FLOOR, MAIN OT COMPLEX, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH
CHANDIGARH 160012 India |
Phone |
7891669817 |
Fax |
|
Email |
drshyam.pgi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shyam Charan Meena |
Designation |
Assistant Professor |
Affiliation |
PGIMER, Chandigarh |
Address |
DEPARTMENT OF ANAESTHEHSIA & INTENSIVE CARE, 4TH FLOOR, MAIN OT COMPLEX, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH
CHANDIGARH 160012 India |
Phone |
7891669817 |
Fax |
|
Email |
drshyam.pgi@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
PGIMER CHANDIGARH |
Address |
DEPARTMENT OF ANAESTHESIA , 4TH FLOOR, MAIN OT COMPLEX, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIAGRH |
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 |
SHYAM CHARAN MEENA |
4th floor elective operation complex ot |
DEPARTMENT OF ANAESTHEHSIA, 4TH FLOOR, MAIN OT COMPLEX, paediatric OT, Eye OT Chandigarh CHANDIGARH |
7891669817
drshyam.pgi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Postgraduate Institute of Medical Education and Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
knowledge and practice of low flow anaesthesia among anaesthesia providers like anaesthesia residents. |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
not applicable |
not applicable |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
all residents will be asked for their knowledge and practice attitude about low flow anaesthesia |
|
ExclusionCriteria |
Details |
participant refusal considered as exclusion criteria |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
to know about knowledge and practice of low flow anaesthesia in tertiary care centre |
AT WORKING OT TIME THAT INCLUDES MORNING 8 AM TO 4 PM, |
|
Secondary Outcome
|
Outcome |
TimePoints |
not available |
6 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
16/07/2018 |
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="0" Months="6" 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
|
Fresh gas flow reduction to less than 1 L/min during maintenance phase of general anaesthesia is well associated with several benefits. Aggrandized preservation of temperature and humidity, money saving through better utilization of inhaled anesthetic agents, and environmental issues are three basic reasons to implementation of low or minimal-flow anesthesia. The benefits and feasibility of low-flow anaesthesia have been already suggested for nearly two decades.2In 1995, Baum and Atikenhead3presented that: ‘‘Although there are potential risks associated with low-flow anesthesia, modern anesthesia machines meet all the technical requirements for the safe use of low-flow techniques if they are used in conjunction with equipment for monitoring inhaled and exhaled gas concentrations; these monitors are already increasingly available and, in the near future, are likely to become an obligatory safety standard in many countries. For both economic and ecological reasons, the use of new inhalational anaesthetics, with low tissue solubility and low anesthetic potency, can be justified only if the efficiency of administration is optimized by using low flow anesthetic techniques.’’ New inhaled anaesthetics, sevoflurane and desflurane, have quite low blood and low tissue solubility, which helps in rapid equilibration between the alveolar and effect site (brain) concentrations and makes them ideally suited for low flow techniques. Modern anaesthesia machines are well designed for low flow anaesthesia techniques, which have leak free circle systems, highly efficient CO2absorbers, and the common practice of utilizing on line real-time multi-gas monitor, including essential alarm systems and many more advanced features, allow for safe and cost effective low flow techniques during maintenance of anesthesia. Few of recent studies also showed that respiratory function and also mucociliary clearance are better preserved with a low flow anesthetic technique as compared with high-flow anesthesia. There are no absolute contraindications to utilizing low-flow anesthesia during elective general anesthesia. Keeping in mind the long-time constants of low-flow techniques, it may not be optimal to use low-flow techniques in emergency cases or in medically complex patients where a rapid adjustment of the inhaled anesthetic concentration may be required. Even though low flow anaesthesia concept is very beneficial and quite easy to learn and practice, it is not so popular in day to day clinical practices even at tertiary care hospital and institute in most of developing countries. Theoretical knowledge and practical implications both are necessary to fulfilling the ultimate aim of any clinical concept. In most of teaching and research institute on floor anaesthesiologists are youngsters like junior and senior anaesthesia residets. Their knowledge and day to day practices towards low flow anaesthesia are very important for actual implications of low flow anaesthesia concept. Therefore, we deiced to assessment of knowledge and practice of low flow anaesthesia by randomly observing their practice in low flow anaesthesia first than we also decided to get their responses via questionnaire. For assessment of low flow anaesthesia practice at our tertiary care hospital, we will be observe the total fresh gas flow (ltr/min) and dial setting of inhalational agents randomly during maintenance of surgical anaesthesia without the knowledge of the ground users. We will also made the questionnaire for assessing the knowledge and clinical practice of low flow anaesthesia in day to day practice. We decided to get responses from young anaesthesiologists including junior and senior residents of anaesthesia from our tertiary care research institute of India. |