| CTRI Number |
CTRI/2020/07/026394 [Registered on: 06/07/2020] Trial Registered Prospectively |
| Last Modified On: |
01/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
To compare insertion of pliable tube through the nose into the stomach in patients under general anaesthesia with a breathing tube through the throat and undergoing laparoscopic gall bladder removal operation in standard sniffing position and with external manipulation of voice box. |
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Scientific Title of Study
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Comparative study of nasogastric tube insertion in anaesthetised intubated patients undergoing laparoscopic cholecystectomy in standard sniffing position and with reverse sellicks manoeuvre: a double blinded randomised control trial. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarbani Ghosh |
| Designation |
Postgraduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Gauhati Medical College and Hospital, Department of Anaesthesiology and Critical care, Bhangagarh, Kamrup Metro
Bhangagarh, Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
8876733961 |
| Fax |
|
| Email |
sarbani1792@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Sanchita Sarma Borkataki |
| Designation |
Assistant Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Gauhati Medical College and Hospital,Department of Anaesthesiology and Critical care,Bhangagarh, Kamrup Metro
Bhangagarh, Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9435046228 |
| Fax |
|
| Email |
sbsarma1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanchita Sarma Borkataki |
| Designation |
Assistant Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Gauhati Medical College and Hospital,Department of Anaesthesiology and Critical care,Bhangagarh, Kamrup Metro
Bhangagarh, Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9435046228 |
| Fax |
|
| Email |
sbsarma1@gmail.com |
|
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Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Guwahati, Assam |
|
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Primary Sponsor
|
| Name |
Dr Sarbani Ghosh |
| Address |
Department of Anaesthesiology and Critical care, Gauhati Medical College and Hospital, Bhangagarh, Kamrup Metro 781032, Assam |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanchita Sarma Borkataki |
Gauhati Medical College and Hospital, Department of Anaesthesiology and Critical Care, Bhangagarh, Kamrup Metro 781032, Assam |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarbani Ghosh |
Gauhati Medical College and Hospital |
Surgery Major Operation Theatre, Department of Surgery
Kamrup
ASSAM |
8876733961
sarbani1792@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gauhati Medical College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reverse Sellicks manoeuvre in Nasogastric tube insertion |
Nasogastric tube will be inserted in anaesthetised intubated patients undergoing laparoscopic cholecystectomy with reverse sellicks manoeuvre at 10 minutes of endotracheal intubation. The maximum number of attempts will be 2. The duration of insertion will be calculated from nasogastric tube insertion to confirmation of its gastric placement by auscultation and the duration should not exceed 90 seconds.
|
| Comparator Agent |
Standard sniffing position in Nasogastric tube insertion |
Nasogastric tube will be inserted in anaesthetised intubated patients undergoing laparoscopic cholecystectomy in standard sniffing position at 10 minutes of endotracheal intubation. The maximum number of attempts will be 2. The duration of insertion will be calculated from nasogastric tube insertion to confirmation of its gastric placement by auscultation and the duration should not exceed 90 seconds.
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients from age of 20 to 60 years taken with American Society of Anaesthesiologists physical status I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia with endotracheal tube insertion. |
|
| ExclusionCriteria |
| Details |
1. Patients with previous pharyngeal, esophageal, stomach surgeries.
2.Patients with history of dysphagia, corrosive ingestion, hematemesis, alcohol intake or cirrhosis.
3.Patients with deformities of chin, pharynx and/or larynx.
4.Patients with deviated nasal septum or with history of nasal obstruction.
5.Esophageal abnormalities like stenosis or varices.
6. Bleeding diathesis.
7. Pregnant patients.
8. At risk of pulmonary aspiration.
9. On anticoagulants or aspirin.
10. Cervical spine pathology.
11. Neck mass.
12. Patients with Gastro Esophageal Reflux Disease.
13. History of radiotherapy in head and neck region.
14. Patients requiring rapid sequence intubation. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare success rate of nasogastric tube insertion in standard sniffing position and in reverse sellicks manoeuvre and to compare time required for successful nasogastric tube insertion in the two groups. |
From insertion of nasogastric tube after patient is intubated (T0) till confirmation of position of nasogastric tube (Tc). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate complication of the procedure such as bleeding, coiling and kinking. |
From insertion of nasogastric tube after patient is intubated (T0) till confirmation of position of nasogastric tube (Tc). |
|
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Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2020 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
It will be sent for publication in peer reviewed journal once the study is over. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
A nasogastric tube (NGT) is commonly inserted into patients undergoing abdominal surgeries to decompress the stomach intra operatively and post operatively, prevent post operative mechanical ileus, administer drugs and allow post operative feeding (1). It also helps to deflate stomach which obscures the view of camera during laparoscopic surgeries and also minimises the chance of gastric perforation(2) .However, in anaesthetised and intubated patients, the NGT gets coiled in oral cavity due to inability to swallow and due to the presence of an inflated cuff in the proximal trachea(2) .The distal part of the NGT has multiple apertures making it the weakest part, and hence increasing its susceptibility to kink, coil and knot, which is also precipitated by warming of the NGT due to body heat during insertion (1,3). Furthermore, repeated trials could induce several complications such as nasal and pharyngeal bleeding, hypertension, tachycardia and arrythmia and several other adverse outcomes (1).The common position that we use for Ryles Tube insertion is the sniffing position (4),which may lead to impaction of the nasogastric tube in the pyriform sinus, arytenoid cartilage or the trachea (5).Different techniques of NGT insertion have been tried like use of guide wire, use of frozen NGT, use of split endotracheal tubes, videolaryngoscope aided methods, and several methods with varying degrees of complications. The reverse Sellick’s manoeuvre is a modified technique of NGT insertion where anterior displacement (lifting) of the cricoid cartilage is done, thus widening the esophageal opening further, to facilitate the insertion of NGT(2) . The major advantage of this technique is simplicity and minimal complication as compared to instrumental facilitation (3).The purpose of this study, is to evaluate the effect of a modified technique of NGT insertion, i.e. Reverse Sellick’s manoeuvre in comparison with the conventional method of insertion, with respect to success rate, time needed for insertion and incidence of bleeding, coiling and kinking . In this randomised control study the null hypothesis that reverse sellick’s manoeuvre does not improve the success rate and time required for nasogastric tube insertion in anaesthetised intubated patients, undergoing laparoscopic cholecystectomy would be investigated.REFERENCE: - Kim HJ, Lee HJ, Cho HJ, Kim HK, Cho AR, Oh N. Nasogastric tube insertion using airway tube exchanger in anesthetized and intubated patients. Korean journal of anesthesiology. 2016 Dec;69(6):568.
- Siddhartha BV, Sharma NA, Kamble S, Shankaranarayana P. Nasogastric tube insertion in anesthetized intubated patients undergoing laparoscopic hysterectomies: A comparative study of three techniques. Anesthesia, essays and researches. 2017 Jul;11(3):550.
- Jonnavithula N, Padhy S, Ravula R, Alekhya G. Comparison of ease of insertion of nasogastric tube in standard sniffing position and in additional flexion of the neck: A randomized control trial. Trends in Anaesthesia and Critical Care. 2019 Mar 23.
- Miller’s Basics of Anaesthesia( 8th edition,2015) 1666-1667
- Mandal MC, Dolai S, Ghosh S, Mistri PK, Roy R, Basu SR, Das S. Comparison of four techniques of nasogastric tube insertion in anaesthetised, intubated patients: A randomized controlled trial. Indian journal of anaesthesia. 2014 Nov;58(6):714.
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