| CTRI Number |
CTRI/2018/01/011346 [Registered on: 15/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [interventional strategies like lecture class, leaflets, posters and one to one discussions] |
| Study Design |
Other |
|
Public Title of Study
|
Study to estimate the efficiency of methods to improve documentation before, during and after anaesthesia for operations |
|
Scientific Title of Study
|
Efficacy of multimodal intervention strategy in improving perioperative anaesthetic documentation in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjit George |
| Designation |
Assistant Professor |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of Anaesthesiology
MOSC Medical College
Kolenchery
Kerala
Ernakulam
KERALA
682311
India |
| Phone |
9447411536 |
| Fax |
|
| Email |
manjitgeorge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D GIRIJANANDAN MENON |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MOSC MEDICAL COLLEGE KOLENCHERY |
| Address |
Department of Anaesthesiology
MOSC Medical College
Kolenchery
Kerala
Ernakulam
KERALA
682311
India |
| Phone |
9447610900 |
| Fax |
|
| Email |
mosc.drdgmenon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D GIRIJANANDAN MENON |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MOSC MEDICAL COLLEGE KOLENCHERY |
| Address |
Department of Anaesthesiology
MOSC Medical College
Kolenchery
Kerala
Ernakulam
KERALA
682311
India |
| Phone |
9447610900 |
| Fax |
|
| Email |
mosc.drdgmenon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
MOSC Medical College
Kolenchery
Kerala |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Manjit George |
MOSC Medical College |
Department of Anaesthesiology
MOSC Medical College
Kolenchery
Kerala682311
Ernakulam
KERALA |
9447411536
manjitgeorge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
status of anaesthesia record maintenance by anaesthesia provider |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
interventional strategies for ideal anaesthesia record keeping
1) leaflets
2) lecture classes
3) posters
4) one to one discussions
5) analysis of pre intervention and post intervention documentation in anaesthesia records |
The anaesthesia records were analysed before providing these interventions. Later, the above mentioned interventional strategies were used to explain to anaesthesia providers, the desired standards of anaesthesia record keeping. This was done over a period of 2 weeks. Following this, the anaesthesia notes recorded by the study participants, were analysed and compared and statistical analysis done. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
anaesthesia records of both elective and emergency cases studied |
|
| ExclusionCriteria |
| Details |
Anaesthesiologists who were not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative anaesthetic documentation efficacy as assessed by a scoring system |
Assessment of 100 cases each before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| difference in adequacy of documentation in elective and emergency cases |
Assessment of 100 cases each before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
05/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/01/2018 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Study has been completed and published .
Doi: 10.5152/TJAR.2020.23682 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study was aimed to assess if multimodal intervention strategies are effective in improving perioperative anaesthetic documentation. Perioperative anaesthetic documentation is an integral part of patient care. Similar study has not been undertaken in our institution and for that matter, literature search didnt give any results from India. we used a scoring system to assess the efficacy of documentation. the same scoring was used to compare pre and post intervention groups. Multimodal intervention strategies included one to one classes, lecture sessions, posters etc. The study has been completed .
Our conclusion is that there is a significant deficiency in perioperative anaesthetic documentation. By creating better awareness of existing guidelines on anaesthetic documentation, multimodal intervention strategies resulted in higher perioperative documentation scores. Scores were lower in emergency cases than in elective cases in both groups. Postoperative instructions for analgesics, fluid and oxygen therapy form an integral part of anaesthetic notes and their importance needs to be emphasised. |