| CTRI Number |
CTRI/2018/05/014284 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study in patients with thyroid neck swelling for placing a tube in trachea using two devices that are Macintosh laryngoscope and Airtraq video laryngoscope |
|
Scientific Title of Study
|
A comparative study between the Macintosh laryngoscope and Airtraq video laryngoscope in thyroid swellings for endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha singh |
| Designation |
junior resident |
| Affiliation |
King george medical university, Lucknow |
| Address |
department of Anaesthesiology,
king georges medical university,
chowk,
Lucknow
room no 503B,
gautam buddha hostel,
king georges medical university,
chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7376101150 |
| Fax |
|
| Email |
pratibha608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Malik |
| Designation |
professor |
| Affiliation |
King george medical university, Lucknow |
| Address |
Department of Anaesthesiology, KGMU,
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9936425729 |
| Fax |
|
| Email |
dranitamalik@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pratibha singh |
| Designation |
junior resident |
| Affiliation |
King george medical university, Lucknow |
| Address |
department of Anaesthesiology,
king george medical university,
chowk,
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7376101150 |
| Fax |
|
| Email |
pratibha608@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology, King george medical university, Lucknow |
|
|
Primary Sponsor
|
| Name |
Pratibha singh |
| Address |
Department 0f Anaesthesiology,
KGMU
Lucknow |
| Type of Sponsor |
Other [[self]] |
|
|
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 |
| Pratibha singh |
King george medical university |
department of anaesthesiology,
King george medical university
Lucknow
UTTAR PRADESH |
7376101150
pratibha608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King george medical university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Thyroid swelling, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Airtraq video laryngoscope for endotracheal intubation
|
new intubation device for tracheal intubation in patients with normal or difficult intubation.
exaggerated curvature of blade and internal arrangement of optical components
view of the glottis is provided without alignment of oral, pharyngeal and tracheal axes |
| Comparator Agent |
Macintosh laryngoscope for endotracheal intubation |
conventional laryngoscope
described in 1943 by Macintosh
curved laryngoscope blade |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 or 2
Mallampatti score 1 or 2 |
|
| ExclusionCriteria |
| Details |
patient not giving informed consent
history of previous neck surgery
history of difficult intubation in any previous surgey
interincisor distance less than 3cm
ASA grade > 2
MPG score 3 or 4 |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time taken in successful intubation |
in seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ease of intubation |
by intubation difficulty score |
| percentage of glottic opening |
POGO score |
| modified Cormack and Lehane grading |
1-4 |
| change in vitals |
heart rate (in beats/min), BP(in mm of Hg) and SpO2(in %) |
| post operative upper airway symptoms |
throat pain and hoarseness of voice |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2017 |
| Date of Study Completion (India) |
30/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to Americal Society of Anaesthesiologists (ASA), difficult airway is the clinical situation in which a conventionally trained anaesthesiologist experiences difficulty with mask ventillation, difficulty with tracheal intubation, or both. ASA defines difficult endotracheal intubation as proper insertion of the tracheal tube with conventional laryngoscopy requires more than three attempts or more than 10 minutes. Operating room cases involving the removal of goiters falls within the difficult airway classificaton. Goiters often involve a number of anatomical locations and results in many implications to the airway and vascular structures. This can lead to upper and lowerairway obstruction, laryngeal malacia, lymphatic and vascular congestion causing edemathat will further compromise the patient’s airway. Keeping in view the difficult airway due to enlarged thyroid swelling, the present study is being done as comparative study between Macintosh laryngoscope and Airtraq video laryngocscope for thyroid swelling has not been done so far. patients will be divided randomly into two groups. preoperatively proper airway assessment and complete systemic examination will be done. written and explained consent will be taken. patients in both groups will be given Fentanyl at 2mcg/kg body weight before induction and will be induced with Propofol at 2mg/kg body weight. after checking for bag and mask ventillation succinylcholine will be given at 2mg/kg body weight. after 1 min of ventillation patient will be intubated with any of the two mentioned methods with an armoured endotracheal tube of appropriate size. then the assessment will be made regarding: 1) time of successful intubation 2) ease of intubation 3) percentage of glottic opening 4) modified Cormack and Lehane grading 5) change in vitals 6) post operative upper airway symptoms |