FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/02/007832 [Registered on: 10/02/2017] Trial Registered Prospectively
Last Modified On: 10/02/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Other 
Public Title of Study   New technique of Rylestube insertion 
Scientific Title of Study   Comparison of the ease of Nasogastric tube insertion in standard sniffing position and with further flexion. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirmala Jonnavithula 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  NIMS, Panjagutta, Hyderabad
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax  9849422749  
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirmala Jonnavithula 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Panjagutta, Hyderabad
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax  9849422749  
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nirmala Jonnavithula 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  NIMS, Panjagutta, Hyderabad
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax  9849422749  
Email  njonnavithula@gmail.com  
 
Source of Monetary or Material Support  
Nizams institute of Medical sciences Panjagutta, Hyderabad 
 
Primary Sponsor  
Name  Nizams institute of medical sciences 
Address  Panjagutta, Hyderabad 
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 J Nirmala   NIMS,Hyderabad  Speciality block operation theatre Surgical Gastroenterology
Hyderabad
ANDHRA PRADESH 
9849422749

njonnavithula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All patients requiring nasogastric tube,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Further Flexion position  Here the rnasogastric tube will be inserted in further neck flexion on standard sniffing position 
Comparator Agent  Sniffing position  Here the nasogastric tube will be inserted in sniffing position 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients coming for elective surgeries, requiring insertion of NG tube
ASA I or II
Age 18 - 65 years
 
 
ExclusionCriteria 
Details  ASA status III, IV,
Bleeding diathesis
Pregnant patients
Patients with risk of pulmonary aspiration of gastric contents,
Patients requiring rapid sequence induction,
Patients with cervical spine pathology,
Patients on anticoagulants or on aspirin
Patients with neck mass,
Patients with raised intracranial tension,
Patients with gastro-esophageal reflux disease, esophageal varices and
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ease if insertion of nasogastric tube in sniffing position and in further flexion position  There is no specific time points for this study. Ease will be assessed at the time of insertion. Necessary manoeuvres will be applied as per the protocol 
 
Secondary Outcome  
Outcome  TimePoints 
bleeding
trauma
coiling , kinking 
Immediately after nasogastric tube insertion 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   07/03/2017 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   it will be published as soon as the study is complete and the data analysed 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

SYNOPSIS

Title:

Comparison of the ease of Nasogastric tube insertion in standard sniffing position and further flexion.”

Background:

Nasogastric tube insertion is a common/mandatory procedure for all major surgical procedures, sometimes it is technically challenging particularly in anesthetised  , paralyzed, and intubated or unconscious patients with reported failure rates of nearly 50% on the first attempt with the head in neutral position.(1-3)  After a failure, subsequent attempts are usually unsuccessful due to coiling, kinking, or knotting of the NG tube as it loses stiffness due to warming to body temperature. The memory effect also contributes to subsequent failures; once kinked, the NG tube is subsequently more likely to kink at the same place. It has been acknowledged that most difficulties in NGT insertions are due to anatomic reasons(4). The most common sites of impaction of the NG tube are piriform sinuses, the arytenoid cartilage(5) and the esophagus, which becomes compressed by the inflated cuff of an endotracheal tube. Maneuvers to keep the NG tube along the lateral or posterior pharyngeal wall during insertion encourages the smooth passage into the esophagus.(1, 2, 4). Common methods used to facilitate NG tube insertion include the use of a slit endotracheal tube, forward displacement of the larynx and the use of various forceps, the use of an ureteral guidewire as a stylet, head flexion, lateral neck pressure, and the use of a gloved finger to steer the NG tube after impaction.(2, 6-8) So far there are no guidelines/protocols/position for its insertion. 

We hypothesized that slight modifications in NG tube insertion technique would improve the rate of successful insertion. We want to study the ease of insertion of NG tube with the head in sniffing position in the first group and in second group the neck will be further flexed by using additional pillow . This study will be unique in nature where it will study the ease of insertion in two different positions sniffing and in further flexion positions and may guide the insertion in difficult scenarios.

AIM

To compare the ease of insertion of NG Tube between the standard sniffing position and in further neck flexion using an additional pillow.  we determine the success rate, average time for insertion.

Secondary end point being incidence of complications, such as bleeding, coiling and kinking.

METHODS

This is a randomized, observational study wherein, one hundred patients will be enrolled. The patients will be randomized into two groups by computer generated random numbers.

Group 1: Here the NG tube will be inserted in the standard sniffing position.

Group 2: the  NG tube is inserted with neck flexed using an additional head ring, then the tube is taken out and reinserted with the head in standard position, i.e with a single head ring. The starting point of the procedure is the time when NG tube insertion is begun. The end point is the time when there is successful insertion of the NG tube.

Failure is defined as:

1.       Not able to insert the tube in 2 attempts,

2.       Using more than one alternative technique such as jaw lift, laryngeal lift, use of laryngoscope, magills,

3.       Time more than 30 sec.

The success rate of the technique, duration of insertion procedure, and the occurrence of complications (bleeding, coiling,) are noted.

Inclusion criteria:

Patients coming for elective surgeries, requiring insertion of NG tube and are

ASA I or II

Age 18 - 65 years

Exclusion criteria:

              ASA status III, IV,

              Pregnant patients

              Patients with risk of pulmonary aspiration of gastric contents,

              Patients requiring rapid sequence induction,

              Patients with cervical spine pathology,

               Patients on anticoagulants or on aspirin

              Patients with neck mass,

              Patients with raised intracranial tension,

              Patients with gastro-esophageal reflux disease and

              Patients with airway distortion or trauma will be excluded from the study

A detailed preoperative assessment with respect to history and examination will be performed. The patients age, sex, weight, height, body mass index (BMI) will be noted, along with the presence of any comorbidities. The following airway assessment measurements will be noted.

1.       Thyro mental distance -  It is defined as the distance from the mentum to the thyroid notch while the patient’s neck is fully extended. This measurement helps in determining how readily the laryngeal axis will fall in line with the pharyngeal axis when the atlanto-occipital joint is extended. Alignment of these two axes is difficult if the T-M distance is < 3 finger breadths or    < 6 cm in adults; 6-6.5 cm is less difficult, while > 6.5 cm is normal.

2.       Sterno mental distance- It’s the distance from the suprasternal notch to the mentum. It is measured with the head fully extended on the neck with the mouth closed.

3.       Neck circumference- It is the circumference of the neck at the level of thyroid cartilage.

4.       Body mass index: calculated as the weight in kilograms divided by the square of the height in meters. Obesity is defined as a body mass index greater than 30kg/m 2 .

5.       Modified Mallampatti grading-

The Mallampatti classification correlates tongue size to pharyngeal size. This test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum.

 

 

Anaesthetic management:

All the patients will be premedicated with Alprazolam 0.5 mg and Ranitidine 150mg night before and on the morning of surgery.

In the operating room, baseline HR, SBP, DBP and SpO2 will be monitored. After obtaining iv access,  Inj. glycopyrrolate 0.1mg intravenous 5 minutes before the induction will be given. Analgesia will be provided with Inj. fentanyl 2mcg/kg intravenously. All the patients will be preoxygenated with 100% oxygen for 3 minutes. Standard induction included Inj. thiopentone 4mg/kg intravenously or till the loss of eyelash reflex and Inj. atracurium 0.5 mg/kg intravenously for muscle relaxation. Using a laryngoscope, intubation will be performed with appropriate sized endotracheal tube.

 

Then the NG tube will be inserted according to the random group that the patient has been assigned.

Group 1: The NG tube is inserted in the standard sniffing position with a single head pillow. In group 2 the head will be further flexed with an additional head pillow and then the nasogastric tube will be inserted.  The ease of insertion will be assessed by the following

The starting point of the procedure is the time when NG tube insertion is begun. The end point is the time when there is successful insertion of the NG tube.

The following manoeuvres will be used if NG tube if  unable to insert in first attempt

First Jaw lift

Laryngeal lift

Use of ureteral guide wire

Use of Magills forceps

Change of nostril.

The success rate of the technique, duration of insertion procedure, and the occurrence of complications (bleeding, coiling,) are noted.

Failure is defined as:

1.       Not able to insert the tube in 2 attempts,

2.       Using more than one alternative technique such as jaw lift, laryngeal lift, use of laryngoscope, magills,

3.       Time more than 30 sec.

 

Data collection:

Airway measurements will be noted during the pre anaesthetic check-up. After induction of anesthesia Nasogastric tube insertion will be performed and the time taken for insertion, need for additional manoeuvres, presence of any complications will be noted.

 

Data analysis:

The time taken for insertion, need for additional manoeuvres, presence of any complications will be noted and statistical analysis will be done using SPSS version 17.1.

 

 

References

1.            Bong CL, Macachor JD, Hwang NC. Insertion of the Nasogastric Tube Made Easy.    Anesthesiology. 2004;101(1):266.

2.            Kayo R, Kajita I, Cho S, Murakami T, Saito H. [A study on insertion of a nasogastric tube in intubated patients]. Masui The Japanese journal of anesthesiology. 2005;54(9):1034-6.

3.            Mahajan R, Gupta R. Another method to assist nasogastric tube insertion. Canadian journal of anaesthesia = Journal canadien d’anesthesie. 2005;52(6):652-3.

4.            Ozer S, Benumof JL. Oro- and nasogastric tube passage in intubated patients: fiberoptic description of where they go at the laryngeal level and how to make them enter the esophagus. Anesthesiology. 1999;91(1):137-43.

5.            Parris WC. Reverse Sellick maneuver. Anesthesia and analgesia. 1989;68(3):423.

6.            Flegar M, Ball A. Easier nasogastric tube insertion. Anaesthesia. 2004;59(2):197.

7.            Sprague DH, Carter SR. An alternate method for nasogastric tube insertion. Anesthesiology. 1980;53(5):436.

8.            Campbell B. A novel method of nasogastric tube insertion. Anaesthesia. 1997;52(12):1234.

 

 

 
Close