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CTRI Number  CTRI/2020/05/024983 [Registered on: 02/05/2020] Trial Registered Prospectively
Last Modified On: 02/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Trial 
Public Title of Study   Usage of topical lignocaine to decrease the gag reflex while sampling for Covid-19: Does it affect the yield of specimen? 
Scientific Title of Study   Usage of topical lignocaine to decrease the gag reflex while sampling for Covid-19: Does it affect the yield of specimen? 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alok Thakar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 4057, 4th floor, teaching block, AIIMS, New Delhi
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  9868397471  
Fax    
Email  drathakar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Alok Thakar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 4057, 4th floor, teaching block, AIIMS, New Delhi
Ansari Nagar, New Delhi

DELHI
110029
India 
Phone  9868397471  
Fax    
Email  drathakar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Alok Thakar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 4057, 4th floor, teaching block, AIIMS, New Delhi
Ansari Nagar, New Delhi

DELHI
110029
India 
Phone  9868397471  
Fax    
Email  drathakar@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS Ansari Nagar New Delhi 
Type of Sponsor  Government medical college 
 
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 Anupam Kanodia  Trauma centre Covid Block, AIIMS, New Delhi  Ansari Nagar, New Delhi 29
South
DELHI 
9968720927

kanodiaanupam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical Lignocaine  Topical lignocaine lozenges to be used before collecting nasal and throat swabs for Covid-19 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  RT-PCR proven COVID19 positive cases  
 
ExclusionCriteria 
Details  Pregnancy, minors, refusal to participate, patient on ventilatory support 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The sensitivity of nasal and throat swabs for RT-PCR of Covid-19 after topical lignocaine use  none 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/05/2020 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary  

Usage of topical lignocaine to decrease the gag reflex while sampling for Covid-19: Does it affect the yield of the specimen?

Introduction

Covid-19  Real Time- Polymerase Chain Reaction (RT-PCR) testing hinges on the undertaking of  nasal/ nasopharyngeal and  oropharyngeal swabs.1,2,3  One of the major challenges while doing this sampling is the gag and cough reflex that  may lead to aerosol generation.4  The gag leads to additional risk to health care personnel. It is also possible that the consequent inadequate or “defensive” sampling may lead to false negative tests.

Otolaryngologists have been using lignocaine lozenges to minimise the gag reflex while performing the pharyngeal and laryngeal procedures. However, before we advocate widespread use of these lozenges for oropharyngeal sampling, we need to know whether these sprays affect the quality of the specimen obtained, causing false negatives or positives. Through this prospective study we wish to assess the effect of topical lignocaine on the quality of the specimen obtained.

Study Objective

Primary objective - To ascertain if a pre-swab lignocaine lozenge affects the quality of the nasal and pharyngeal swab taken to conduct of the RT-PCR Covid-19 test.

Methodology

Study design- Prospective study

Study population- Adult patients testing positive on the RT-PCR Covid-19 test undertaken as per standard practice (no topical lignocaine) at AIIMS, New Delhi will be included after a written informed consent.

Exclusion criteria- Minors, pregnant ladies, patients refusing to participate in the study, patients with history of hypersensitivity to lignocaine and patients on ventilator support will be excluded. 

Sample size (N) = 30

Sample collection procedure- The pharyngeal swab shall be repeated within 72 hours of the first swab tested as positive. Unlike the first swab (Gold Standard) the second swab would be taken after xylocaine anaesthesia.

Topical xylocaine anaesthesia would be administered by the patient sucking a lignocaine lozenge (200 mg) to achieve local pharyngeal anaesthesia. The repeat swab shall be taken after 3-5 minutes of the local anaesthetic application.

 

Laboratory procedure- The repeat throat and nasal swab shall be tested as per usual procedure by qualitative reverse transcription real-time Polymerase Chain Reaction (RT-PCR) for detection of SARS Coronavirus-2 RNA.

 

Statistical analysis- The sensitivity of the second “swab with anaesthesia” shall be compared with the Gold Standard initial swab without anaesthesia 

References

1.        Wang W, Xu Y, Gao R, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. March 2020. doi:10.1001/jama.2020.3786

2.        Zou L, Ruan F, Huang M, et al. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020;382(12):1177-1179. doi:10.1056/NEJMc2001737

3.        Kim C, Ahmed JA, Eidex RB, et al. Comparison of nasopharyngeal and oropharyngeal swabs for the diagnosis of eight respiratory viruses by real-time reverse transcription-PCR assays. PLoS One. 2011;6(6):e21610-e21610. doi:10.1371/journal.pone.0021610

4.        van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. March 2020. doi:10.1056/NEJMc2004973

 
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