| CTRI Number |
CTRI/2024/04/065832 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To check the extend of stomach distension after oxygenating the patient with traditional Face mask and a new device called High flow nasal cannula |
|
Scientific Title of Study
|
To evaluate the effect of Face mask ventilation or High flow nasal oxygen on gastric volume during anaesthesia induction in patients undergoing Laparoscopic surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VIGNESHWAR J R |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department Of Anaesthesiology, DR. B R Ambedkar
Medical College And Hospital,
K G Halli, Shampura mainroad
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
7795846652 |
| Fax |
|
| Email |
vigneshwar.jawali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARSOOR S S |
| Designation |
HEAD OF THE DEPARTMENT AND PROFESSOR |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department Of Anaesthesiology, DR. B R Ambedkar
Medical College And Hospital, K.G.Halli, Shampura mainroad
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIGNESHWAR J R |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department Of Anaesthesiology, DR. B R Ambedkar
Medical College And Hospital, K.G. Halli, Shampura mainroad
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
7795846652 |
| Fax |
|
| Email |
vigneshwar.jawali@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY
DR. B.R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,
K.G.HALLI, BENGALURU – 560045. KARNATAKA,INDIA
|
|
|
Primary Sponsor
|
| Name |
VIGNESHWAR J R |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R AMBEDKAR
MEDICAL COLLEGE AND HOSPITAL, K G HALLI, SHAMPURA
MAINROAD
Bangalore
KARNATAKA
560045
India
|
| Type of Sponsor |
Other [SELF] |
|
|
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 VIGNESHWAR J R |
DR.B.R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
OT COMPLEX,
DEPARTMENT OF
ANAESTHESIOLOGY,
K G
HALLI,SHAMPURA
MAINROAD 560045
Bangalore
KARNATAKA,INDIA
Bangalore
KARNATAKA |
7795846652
vigneshwar.jawali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Face mask |
Traditonal face mask used for preoxygenation |
| Intervention |
High Flow Nasal oxygenation |
Administration of oxygen through high flow nasal cannula At 70l/min during preoxygenation period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective laparoscopic surgeries under general anaesthesia belonging to ASA Class 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Gastro intestinal reflux disorder patients
2.Patients with upper respiratory tract infection
3.previous history of difficult intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in gastric antral cross-sectional area by ultrasonography. |
before preoxygenation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine incidence of gastric insufflation of stomach by direct laparoscopic view by surgeon.
2.To determine incidence of regurgitation and aspiration.
|
after the time anaesthesia induction |
|
|
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)
|
22/05/2024 |
| 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="6"
Days="18" |
|
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
|
. A high inspiratory
pressure is known to cause gastric insufflation during facemask ventilation.
Therefore, the effect HFNO can be
compared as an alternative to facemask on gastric volume. However, in patients
undergoing laparoscopic surgery, the increase in gastric volume is a common
concern of anaesthesiologists and surgeons. Gastric insufflation may affect the
surgical visual field, prolong the operation time and also cause gastric
contents regurgitation, aspiration pneumonitis and stomach perforation,
Distension of the gastric antrum triggers a para-sympathetic reflex that
results in increased secretions of gastric acid, thereby increasing the
mortality risk. In previous studies, the occurrence of gastric insufflation was
determined by auscultation with a stethoscope over the epigastrium; however,
the reliability and accuracy of this method are uncertain. With abdominal ultrasound,
we can detect the excessive presence of air in the stomach and accurately
estimate the gastric volume through the measurement the gastric antral
cross-sectional area (CSA). |