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CTRI Number  CTRI/2015/02/005535 [Registered on: 12/02/2015] Trial Registered Prospectively
Last Modified On: 11/02/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Post operative sore throat after anaesthesia 
Scientific Title of Study   THE IMPACT OF TRACHEAL TUBE INTRODUCER GUIDED INTUBATION IN ANTICIPATED NON DIFFICULT AIRWAY ON POST OPERATIVE SORE THROAT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amitabh Dutta 
Designation  Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Department of Anaesthesiology Pain & Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar

Central
DELHI
110060
India 
Phone  09810848064  
Fax    
Email  duttaamitabh@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amitabh Dutta 
Designation  Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Department of Anaesthesiology Pain & Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar

Central
DELHI
110060
India 
Phone  09810848064  
Fax    
Email  duttaamitabh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Sethi 
Designation  Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Department of Anaesthesiology Pain & Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar

Central
DELHI
110060
India 
Phone  09717494498  
Fax    
Email  nitinsethi77@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain & Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar  
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain Perioperative Medicine  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar 110060 New Delhi India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Amitabh Dutta  Department of Anaesthesiology Pain & Perioperative Medicine 5th Floor SSRB   Sir Ganga Ram Hospital Old Rajinder Nagar 110060
Central
DELHI 
09810848064

duttaamitabh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  elective surgery under general anaesthesia requiring endotracheal intubation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group I Non-TTI group  Endotracheal intubation will be done using conventional direct laryngoscopy and tracheal tube introducer aid will not be utilised 
Comparator Agent  Group II Rigid-TTI group  Endotracheal intubation will be facilitated with rigid tracheal tube introducer 
Comparator Agent  Group III Non Rigid-TTI group  Endotracheal intubation will be facilitated with flexible non-rigid tracheal tube introducer 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA physical status I/II
2.Short-to-moderate duration surgery(up to 3-hours)under general anaesthesia with controlled ventilation 
 
ExclusionCriteria 
Details  1.Anticipated difficult airway.
2.Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients).
3.Neurosurgical patients with active ICP considerations.
4.History of airway related morbidity (POST, mucosal trauma)
5.Recent head and neck, intraoral/nasal surgery.
6.Psychiatric and substance abuse patients.
7.Ongoing upper and lower respiratory tract inflammation/infection.
8.Bleeding diathesis, steroid dependence
9.Consent refusal
 
 
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 
1.To evaluate the impact of tracheal-tube introducer guided intubation on incidence of postoperative sore throat  From arrival in the postoperative recovery room till 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
1.Intubation attempts
2.Laryngoscopy-intubation time
3.Intubation response (hemodynamic: heart rate, NIBP: systolic, diastolic, mean blood pressure)
4.Trauma (lips, mucosal [oral, pharyngel, laryngeal])
5.Airway-related complications: laryngo/bronchospasm, inspiratory stridor, postoperative airway obstruction
 
From induction of anaesthesia till end of endotracheal intubation 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="450" 
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)   24/02/2015 
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="2"
Days="10" 
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  

Postoperative sore throat (POST) is a longstanding common negative anesthesia outcome after general anesthesia (GA) wherein conventional direct laryngoscopy-intubation (DLI) technique is employed to control upper airway. Various reasons have been placed forth and corresponding measures undertaken (e.g. tracheal tube cuff pressure control) to preclude/diminish the impact of POST but in vain. Till date, none of the efforts to prevent POST have considered mechanical factors associated with DLI as a contributing factor of POST. Since the only ‘active’ mechanical event during upper airway management comprises DLI, we presume that modification of DLI technique will reduce the forces associated with the technique and consequently, bring down incidence/severity of POST. Tracheal tube introducers (TTI), introduced to facilitate intubation in difficult airway settings, have only been employed once to improve quality-of-DLI in non-difficult airway (NDA) settings, that too with limited success. We speculate that the forces related to DLI, including, 1. Laryngoscopic mandibular lift (to expose the glottis-opening), and 2. Frictional forces generated when a tracheal tube passes the vocal cords to get into the trachea; are likely to be lesser when a tracheal-tube is guided inside the trachea with the help of a TTI. This study intends to evaluate the use of TTI in NDA in terms of their ability to bring down the impact of active DLI forces during upper airway access, and consequently, on the incidence of POST.

 
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