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
|
|
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
|
|
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. |