| CTRI Number |
CTRI/2024/07/071356 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [comparing trauma caused nasogastric tube insertion by oral route versus nasal route ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to compare injury caused by nasogastric tube by nasal route versus oral route in patients undergoing surgical laparoscopic procedures at northern Railway Central Hospital , New Delhi ,India |
|
Scientific Title of Study
|
Randomized control trial to evaluate incidence of trauma during nasogastric tube insertion by nasal route versus oral route in patients receiving general anaesthesia for laparoscopic procedures |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puneet Bhagat |
| Designation |
DNB Anaesthesia resident |
| Affiliation |
Northern Railway Central Hospital , New Delhi |
| Address |
Anaesthesia Department , Northern Railway Central Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9540305300 |
| Fax |
|
| Email |
drpuneetbhagat.irms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A K Sharma |
| Designation |
Sr. Consultant, NRCH |
| Affiliation |
Northern Railway Central Hospital |
| Address |
Anaesthesia Department , Northern Railway Central Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9717630508 |
| Fax |
|
| Email |
dr_aksharma@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A K Sharma |
| Designation |
Sr. Consultant, NRCH |
| Affiliation |
Northern Railway Central Hospital |
| Address |
Anaesthesia Department , Northern Railway Central Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9717630508 |
| Fax |
|
| Email |
dr_aksharma@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital, Basant lane, New Delhi, pin code 110001, India |
|
|
Primary Sponsor
|
| Name |
no sponsor |
| Address |
not applicable |
| Type of Sponsor |
Other [no 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 |
| Dr Puneet Bhagat |
Northern Railway Central Hospital |
Operation Theatre no-1 and 2 , First floor ,
Anaesthesia Department
New Delhi
DELHI |
9540305300
drpuneetbhagat.irms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Northern Railway Central, IEC-NRCH |
Approved |
| Institutional ethics committee Northern Railway Central, IEC-NRCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (2) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (3) ICD-10 Condition: K37||Unspecified appendicitis, (4) ICD-10 Condition: K389||Disease of appendix, unspecified, (5) ICD-10 Condition: K450||Other specified abdominal hernia with obstruction, without gangrene, (6) ICD-10 Condition: K509||Crohns disease, unspecified, (7) ICD-10 Condition: K567||Ileus, unspecified, (8) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (9) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (10) ICD-10 Condition: K811||Chronic cholecystitis, (11) ICD-10 Condition: K839||Disease of biliary tract, unspecified, (12) ICD-10 Condition: K831||Obstruction of bile duct, (13) ICD-10 Condition: K835||Biliary cyst, (14) ICD-10 Condition: K838||Other specified diseases of biliary tract, (15) ICD-10 Condition: K769||Liver disease, unspecified, (16) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (17) ICD-10 Condition: C228||Malignant neoplasm of liver, primary, unspecified as to type, (18) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, (19) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, (20) ICD-10 Condition: N209||Urinary calculus, unspecified, (21) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, (22) ICD-10 Condition: O009||Ectopic pregnancy, unspecified, (23) ICD-10 Condition: O283||Abnormal ultrasonic finding on antenatal screening of mother, (24) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
measure trauma caused by nasogastric tube placement by nasal route in laparoscopic procedures under general anaesthesia |
At the time of removal of nasogastric tube when patient undergoing laparoscopic surgery under general anaesthesia in operation theatre , trauma will be assesses on visual injury caused 1)no visible trauma, 2) nasogastric tube having visible blood on it 3) Blood upto 1 ml of blood loss 4) blood loss more than 1 ml blood loss |
| Intervention |
measure trauma caused by nasogastric tube placement by oral route in laparoscopic procedures under general anaesthesia |
At the time of removal of nasogastric tube when patient undergoing laparoscopic surgery under general anaesthesia in operation theatre , trauma will be assesses on visual injury caused 1)no visible trauma, 2) nasogastric tube having visible blood on it 3) Blood upto 1 ml of blood loss 4) blood loss more than 1 ml blood loss |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-All Surgical cases posted for laparoscopy procedures under general anaesthesia
-All cases between 16-80 years of age |
|
| ExclusionCriteria |
| Details |
Patients having history of Corrosive poisoning, Severe mid face and head trauma, Recent nasal surgery, oesophageal varices or oesophageal strictures, clotting abnormalities, nasopharyngeal pathology, oropharyngeal pathologies, patients having visible trauma during endotracheal tube intubation.
|
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|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-To compare incidence of trauma during Nasogastric tube insertion by nasal route and oral route in patients
receiving general anaesthesia for laparoscopic procedures. |
1) at the time of placement of nasogastric tube.
2)-At the time of removal of nasogastric tube. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-To compare success rate of Nasogastric tube insertion between two test groups in terms of number of
insertion.
2-To measure ease of Nasogastric tube insertion by nasal route & oral route in terms of additional measures
and interventions. |
1- At the time of placement of nasogastric tube.
2-at the time of placement of nasogastric tube. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drpuneetbhagat.irms@gmail.com].
- For how long will this data be available start date provided 04-09-2026 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
recruitment will be done only after permission and CTRI registration number |