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CTRI Number  CTRI/2024/08/072113 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How compression of soft tissue technique compared to conventional method increases success rate of nasogastric tube insertion: A research study 
Scientific Title of Study   Comparison of Nasogastric tube insertion using conventional technique versus compression of soft tissues technique in intubated patient 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish shrestha 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Room no 5011, Anaesthesiology office,Department of Anaesthesiology,Pain Medicine and Critical care,5th floor,AIIMS New Delhi 110029 South Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone  9170032844  
Fax    
Email  mansht25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhishek Nagarajappa 
Designation  Associate Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 5011,Anaesthesiology Office,Department of Anaesthesiology,Pain Medicine and Critical care,5th floor,New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  abhishek.nagarajappa@outlook.com  
 
Details of Contact Person
Public Query
 
Name  Manish shrestha 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Room no 5011,Anaesthesiology Office,Department of Anaesthesiology,Pain Medicine and Critical care,5th floor,New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  9170032844  
Fax    
Email  mansht25@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Pain Medicine and Critical care, AIIMS, New Delhi, Ansari Nagar 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anaesthesiology,Pain Medicine and Critical Care AIIMS New Delhi,Ansari Nagar,New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish shrestha  AIIMS, New Delhi  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi
New Delhi
DELHI 
09170032844

mansht25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee for post graduate research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasogastric tube insertion using compression of soft tissues technique (COST)in intubated patients  Using the non-dominant hand of the person doing the procedure, soft tissues under the mandible will be compressed so that the tongue is approximated onto hard and soft palate. Then with the dominant hand, a lubricated nasogastric tube will be inserted through the patent nostril into the gastric cavity.  
Comparator Agent  Nasogastric tube insertion using conventional technique  Using the dominant hand of the person performing the procedure, a lubricated NGT will be inserted in the patent nostril upto a premeasured length (SMD+SXD). No other maneuver will be used to aid in the insertion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  surgery under general anesthesia more than 18 years.
ASA I, II, and III 
 
ExclusionCriteria 
Details  Refusal to participate
BMI more than 30 Kg/m2
History of any previous nasal surgery
Presence of intraoral or intranasal mass
History of trauma, skull base fracture
Airway distortion
7. Bleeding Diathesis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the First pass success rate between the conventional vs compression of soft tissues technique  Immediately after insertion of Nasogastric tube. Time 0 minute 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken for insertion
2. Causes for failure (Coiling, kinking ,overinflated ETT cuff)
3. Incidence of any Complication associated with NGT insertion
 
1. Time taken from the start of NGT insertion till Immediately after Nasogastric tube insertion.
2. immediately after NGT insertion at Time 0.
3. immediately after NGT insertion at Time 0.  
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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)   20/08/2024 
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="2"
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  

 A nasogastric tube is a flexible tube designed to pass through the nasal cavity into the gastric cavity. It is used for providing nutrition and medication in intubated patients (e.g., conditions with dysphagia such as head and neck cancers, altered mental status, etc.) and gastric decompression to relieve pressure (e.g., patients undergoing abdominal laparoscopic surgery) and decompression (e.g., after ingestion of harmful poisons such as organophosphorus poisoning, gastric outlet obstruction and small bowel obstruction).  [1-5]

Numerous techniques are available for Nasogastric tube insertion with variable first pass success rates ranging between 63%-76%, such as forward displacement of the larynx, lateral rotation of the neck, use of a split endotracheal tube, use of various kinds of forceps, etc. [6-9]  Various reasons are attributed for failure in insertion at the first attempt, such as Intraoral coiling due to inability of the patient to swallow, presence of an inflated cuff in the proximal trachea, fall of oesophagus onto the posterior pharyngeal wall, causing mechanical obstruction. [10] The nasogastric tube multi-aperture distal part often makes it susceptible to kinking and coiling, with mucosal tears with resultant bleeding. Impaction at the arytenoids and pyriform fossae is another common occurrence. [6] Hence, we have to adjust our manoeuvres to slide the nasogastric tube along the posterior pharyngeal wall to facilitate a smoother passage into the oesophagus.

Nasogastric tube insertion is associated with numerous complications, such as injury to nasal turbinates, oesophagus, or gastric mucosa, leading to mucosal tears and bleeding. It is also associated with sinus infection and electrolyte imbalances such as hypokalemia. [6] Rarely, Nasogastric tube insertion may result in accidental placement of the NGT in the airway, causing infiltration of the lungs. [11] 

We have described and used a novel technique for NGT insertion called Compression Of Soft Tissues (COST). We hypothesise that by compression of Soft tissues in the floor of the mouth, the tongue is approximated with the hard and soft palate. This decreases intraoral space, reduces intraoral coiling of the nasogastric tube and improves the success rate of insertion in the first attempt. We have planned to compare our novel COST technique with the conventional (CONT) technique of NGT insertion with the head in a neutral position in anaesthetised and intubated patients undergoing abdominal surgery. We aim to determine their success rate, time taken for insertion and incidence of any complications such as bleeding and coiling.

AIMS AND OBJECTIVES

 

 

This study will aim to investigate the difference in the first-attempt success rates, time taken for insertion, and complication rates between the two different techniques for the insertion of a nasogastric tube.

 

Primary objective:

·       To compare the First pass success rate between the two techniques.

 

Secondary objectives:

·       Time taken for insertion

·       Causes for failure (Coiling,, kinking overinflated ETT cuff)

·       Incidence of any Complication associated with NGT

After procuring informed written consent, all the patients included in the study will be randomised using a computer-generated random table into one of two groups: Group CONT (insertion using conventional technique) and Group COST (insertion using compression of soft tissues technique).

Following airway measurements will be noted in the preoperative period: Sterno-mental distance(SMD), Sterno-xiphoid distance (SXD), and body mass index (BMI).

On the patient’s arrival to the operating room, a peripheral venous catheter will be established; Standard monitors will be attached. General anaesthesia induction will be standard with intravenous fentanyl 2mcg/kg, propofol 2mg/kg and atracurium 0.5mg/kg. An appropriate-sized endotracheal tube will be inserted into the trachea under direct laryngoscopy.

Nasogastric tube insertion technique: In both groups, the head of the patient will be kept in a neutral position without any flexion or extension. A well-lubricated 14 Fr NGT will be used for insertion.

Group CONT: In this group, using the dominant hand of the person performing the procedure, a lubricated NGT will be inserted in the patent nostril up to a premeasured length (SMD+SXD). No other manoeuvre will be used to aid in the insertion.

Group COST: In this group, using the non-dominant hand of the person doing the procedure, soft tissues under the mandible will be compressed so that the tongue is approximated onto the hard and soft palate. Then, with the dominant hand, a lubricated NGT will be inserted through the patent nostril into the gastric cavity. No other manoeuvre will be used to aid in the insertion.

Confirmation of the gastric placement of NGT will be done by using the Syringe-woosh test (injection of 10ml of air via a nasogastric tube with simultaneous auscultation over the epigastrium). The technique will be considered a success if the Syringe-woosh test is positive (successful auscultation of injected air over the epigastrium). Similarly, it will be regarded as a failure if the Syringe-woosh test is negative (failure to auscultate injected air over the epigastrium).

If the first attempt fails, the NGT will be fully withdrawn, cleaned, and lubricated, and the procedure will be repeated using the same technique without any additional manoeuvre. If two attempts for insertion are unsuccessful, the selected technique will be considered as an overall failure. In case of two failed attempts, NGT will be inserted with the assistance of a laryngoscope and Magill forceps under direct vision.

Bleeding due to trauma will be confirmed by blood staining of the nasogastric tube after removal or blood in the nasal cavity/oral cavity. Prophylactic laryngoscopy will be done to check for intraoral bleeding after confirmation of accurate placement of the nasogastric tube.

The following parameters will be noted:

Success rate of selected technique (first attempt, second attempt, overall)

Time taken for successful insertion

Complications of the procedure such as kinking, coiling or bleeding.

 

Statistical Analysis;

Categorical variables will be expressed as numbers and percentages. Data will be expressed as mean (± SD) or as median (± interquartile range) when appropriate.

 

Outcome parameters:

 

·        Primary outcome: Firsts attempt success rate

·        Secondary outcomes:

o    Number of attempts needed to insert nasogastric tube

o    Time for insertion

o    Bleeding incidence

o    Complications associated with NGT

REFERENCES

1.     Leong SC, Mahanta V. Securing the nasogastric tube in head and neck cancer patients. The Laryngoscope. 2006;116(11):2089–91.

2.     Doley J. Enteral nutrition overview. Nutrients0. 2022;14(11):2180.

3.     Lee JH, Hyung WJ, Noh SH. Comparison of gastric cancer surgery with versus without nasogastric decompression. Yonsei Medical Journal. 2002;43(4):451.

4.     Li Y, Tse ML, Gawarammana I, Buckley N, Eddleston M. Systematic review of controlled clinical trials of gastric lavage in acute organophosphorus pesticide poisoning. Clinical Toxicology. 2009;47(3):179–92.

5.     Tan JH, Sivadurai G, Tan HCL, Tan YR, Jahit S, Hans Alexander M. A novel method of Nasojejunal feeding and gastric decompression using a double lumen silicone tube for upper gastrointestinal obstruction. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques. 2020;30(2):106–10.

6.     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;26–27:48–51.

7.     Sanaie S, Mirzalou N, Shadvar K, Golzari SE, Soleimanpour H, Shamekh A, et al. A comparison of nasogastric tube insertion by sort maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure in critically ill patients admitted to ICU: A prospective randomized clinical trial. Annals of Intensive Care. 2020;10(1).

8.     Illias AM, Hui Y-L, Lin C-C, Chang C-J, Yu H-P. A comparison of nasogastric tube insertion techniques without using other instruments in anesthetized and intubated patients. Annals of Saudi Medicine. 2013;33(5):476–81.

9.     Mandal M, Karmakar A, Basu S. Nasogastric tube insertion in anaesthetised, intubated adult patients: A comparison between three techniques. Indian Journal of Anaesthesia. 2018;62(8):609.

10.  Ou G-W, Li H, Shao B, Huang L-M, Chen G-M, Li W-C. Comparison of different methods of nasogastric tube insertion in anesthetized and intubated patients: A meta-analysis. World Journal of Clinical Cases. 2021;9(26):7772–85.

11.  EuroSurg Collaborative. Timing of nasogastric tube insertion and the risk of postoperative pneumonia: an international, prospective cohort study. Colorectal Dis. 2020 Dec;22(12):2288-2297.

12.  Kavakli AS, Kavrut Ozturk N, Karaveli A, Onuk AA, Ozyurek L, Inanoglu K. Comparison of different methods of nasogastric tube insertion in anesthetized and intubated patients. Brazilian Journal of Anesthesiology (English Edition). 2017;67(6):578–83.

13.  Appukutty, J. and Shroff, P.P. (2009) ‘Nasogastric tube insertion using different techniques in anesthetized patients: A prospective, randomized study’, Anesthesia & Analgesia, 109(3), pp. 832–835.

14.  Zhao, W. et al. (2017) ‘The important role of positioning in nasogastric tube insertion in unconscious patients: A prospective, randomised, double‐blind study’, Journal of Clinical Nursing, 27(1–2).

15.  Mandal M, Karmakar A, Basu S. Nasogastric tube insertion in anaesthetised, intubated adult patients: A comparison between three techniques. Indian Journal of Anaesthesia. 2018;62(8):609.


 
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