| CTRI Number |
CTRI/2020/02/023242 [Registered on: 11/02/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison between two different methods of nasogastric tube insertion; the SORT method and blind insertion, in adult patients who have received general anaesthesia. |
|
Scientific Title of Study
|
Nasogastric tube insertion in anaesthetised, intubated, adult patients: a comparison between the conventional method and the SORT manoeuvre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saroojini Divyaa Dhakal |
| Designation |
Post-Graduate Student, Department of Anaesthesiology |
| Affiliation |
Nil Ratan Sircar Medical College |
| Address |
Department of Anaesthesiology, Ground Floor, U&B building, Nil Ratan Sircar Medical College, 138, A.J.C Bose Road, Sealdah, Kolkata, West Bengal.
Kolkata
WEST BENGAL
700014
India |
| Phone |
07834817592 |
| Fax |
|
| Email |
sarojdhakal33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohanchandra Mandal |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Nil Ratan Sircar Medical College |
| Address |
Department of Anaesthesiology, Ground Floor, U&B Building, Nil Ratan Sircar Medical College, 138, A.J.C Bose Road, Sealdah, Kolkata-14, West Bengal.
Kolkata
WEST BENGAL
700014
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohanchandra Mandal |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Nil Ratan Sircar Medical College |
| Address |
Department of Anaesthesiology, Ground Floor, U&B Building, Nil Ratan Sircar Medical College, 138, A.J.C Bose Road, Sealdah, Kolkata-14, West Bengal.
Kolkata
WEST BENGAL
700014
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil Ratan Sircar Medical College and Hospital. |
|
|
Primary Sponsor
|
| Name |
Nil Ratan Sircar Medical College and Hospital |
| Address |
138, A.J.C Bose Road, Sealdah, Kolkata-14, West Bengal. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrSaroojini D Dhakal |
Nil Ratan Sircar Medical College |
Central OT (Sushruta OT), Nil Ratan Sircar Medical College, 138, AJC Bose Road, Sealdah, Kolkata-14
Kolkata
WEST BENGAL |
07834817592
sarojdhakal33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRSMCH Institutional Ethics Committee |
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 |
Conventional blind nasogastric tube insertion |
This procedure is done by placing the head of the intubated, anaesthetised patient in the neutral position, and then inserting the nasogastric tube gently upto the desired length. |
| Intervention |
SORT Manoeuvre |
This manoeuvre involves placing patients head in sniffing position, orientation of the nasogastric tube from nose to the oesophageal entrance, rotation of the head to the contralateral side, with or without pressure at the pyriform fossa, and twisting motion of the NGT during insertion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients undergoing elective abdominal surgeries, that require intra-operative nasogastric tube insertion.
2.Patients that have given written informed consent to participating in the study. |
|
| ExclusionCriteria |
| Details |
1.Anatomical/structural abnormalities such as cleft lip, cleft palate, deviated nasal septum etc.
2.Patients with oral, nasal, pharyngeal or oesophageal masses.
3.Patients with significant injuries involving the head and neck region.
4.Patients with thrombocytopenia or coagulopathies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of successful insertions in a single attempt |
After completion of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for insertion |
At the time of insertion |
| Adverse events occurring during insertion |
At the time of insertion
|
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/02/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, single-blind (patient blind) , parallel group, active-controlled study, comparing the success rate of correct nasogastric tube placement using either the SORT Manoeuvre or the conventional blind technique, in 160 (80 in each group) anaesthetised, intubated patients, over a time period of approximately 1 year, in a single centre. The primary outcome measure will be the proportion of patients with successful nasogastric tube placement in the first attempt, using either of the methods. The secondary outcome measures will be the procedure time, as well as any adverse events occurring during the procedure. The observations will be analysed using appropriate statistical methods with the help of an expert. |