| CTRI Number |
CTRI/2024/02/062485 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficiency of Mobile App |
|
Scientific Title of Study
|
Efficiency of Mobile App Compared to conventional method of preanesthetic Assessment: A Pilot Study |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujeet Kumar Singh gautam |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post-graduate Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
SGPGIMS, Raebareli Road,
LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974046 |
| Fax |
|
| Email |
docsksg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GURUDAYAL KHARE |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Post-graduate Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
SGPGIMS, Raebareli Road,
LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
7566292081 |
| Fax |
|
| Email |
gurudayalkhare5867@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GURUDAYAL KHARE |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Post-graduate Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
SGPGIMS, Raebareli Road,
LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
7566292081 |
| Fax |
|
| Email |
gurudayalkhare5867@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post-graduate Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post-graduate Institute of Medical Sciences |
| Address |
SGPGIMS, Raibareli Road, Lucknow-226014 |
| 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 |
| Dr Sujeet Kumar Singh Gautam |
Sanjay Gandhi Post-graduate Institute of Medical Sciences |
Department of Anaesthesiology, Room number 17, A Block, SGPGIMS, Raibareli Road, Lucknow-226014
Lucknow
UTTAR PRADESH |
8765974046
docsksg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients(18-65years) of either sex, ASA physical status I or II, who are admitted for surgical intervention in the hospital will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients unable to communicate via Mobile apps
History of Dyspnoea on exertion
History of respiratory disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficiency of mobile app compared to conventional method of preanesthetic assessment of patients undergoing surgical intervention. This will be assessed by identification of patients in which risk factors or disorders remain unidentified during PAE by mobile App. |
At the time of preanesthetic assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difficult Airway prediction
Patient’s ability to complete the preanesthetic evaluation (PAE) by mobile app
Patient’s willingness to participate in mobile App PAE again
Patient Satisfaction: It will be assessed as 5: very satisfied; 4 satisfied; 3 somewhat satisfied; 2 Not satisfied; 1 very unsatisfied
|
At the time of preanesthetic assessment |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
14/02/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre-anesthesia evaluation (PAE) allows discovery of conditions affecting peri-operative planning. Inadequate pre-anesthesia evaluation is associated with delays, cancellations and preventable adverse events. Use of mobile app for pre-anaesthetic evaluation may reduce the time and efforts required by a patient for pre-anesthetic evaluation. Study will be conducted after approval from the Institute’s ethical committee and obtaining written informed consent from the patients. Inclusion criteria are patients scheduled for surgical intervention under general anesthesia, adult patients (18-65 yrs) of either sex and ASA physical status I and II. Exclusion criteria are patient refusal, illiterate patient or unable to operate mobile phones, history of dyspnea on exertion and history of respiratory disease. Our primary outcome is Efficiency of mobile app compared to conventional method of preanesthetic assessment of patients undergoing surgical intervention. This will be assessed by identification of patients in which risk factors or disorders remain unidentified during PAE by mobile App. Secondary outcome is Difficult Airway prediction; Patient’s ability to complete the preanesthetic evaluation (PAE) by mobile app; Patient’s willingness to participate in mobile App PAE again; Patient Satisfaction. A patient scheduled for surgical intervention will be enrolled in the study after telephonic interview by an anesthesiology resident. Contact number of the patient will be provided to the anesthesiology resident by the surgical team. The patients enrolled in the study will undergo Mobile app pre- anesthetic Evaluation (PAE) by the mobile App (SGPGI Patient Doctor communication App). the anesthesiology resident will share the App link with the patient. The patient will be advised to answer the PAE questionnaire in the App. The mobile App is developed as a part of the intramural research project A-1- View -PGI/IMP/80/2019 entitled “Development of an App for Patient Doctor Communication minimizing patient OPD visitsâ€. Physical PAE will be done by an anesthesiology resident after the patient has completed PAE by the mobile app. PDF file of physical PAE will be shared with an anesthesiology consultant not involved in the study; the consultant will evaluate the PAE done by the two methods to assess the possibility of incomplete pre-anesthetic evaluation by mobile App. This will be assessed by identification of unrecognized risk factors or disorders during physical PAE done after PAE by mobile App. Sample size calculation has been done by assuming that a 15% difference in thepossibility of identifying risk factors or disorders during pre-anesthetic evaluation by mobile app as compared to physical method done on the same patient, at minimum two-sided 95%confidence interval and 80% power of the study, estimated sample size is 59. Sample size wascalculated using software "Power analysis and sample size version-16 (PASS-16). |