CTRI Number |
CTRI/2017/02/007968 [Registered on: 27/02/2017] Trial Registered Retrospectively |
Last Modified On: |
26/02/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparing success of putting artificial tube in windpipe by using a thin wire or a thick introducer for guidance |
Scientific Title of Study
|
Comparison of success of intubation and
laryngeal morbidity in Bougie versus Wire
guided intubation
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Thooyamani Ponnusamy |
Designation |
Junior Resident,Anaesthesiology |
Affiliation |
Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER) |
Address |
Department of Anaethesiology and critical care, Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER),
Dhanvantri Nagar,,
Puducherry.
Pondicherry PONDICHERRY 605006 India |
Phone |
9941032921 |
Fax |
|
Email |
drthooyamani200888@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Thooyamani Ponnusamy |
Designation |
Junior Resident, Anaesthesiology |
Affiliation |
Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER) |
Address |
Department of Anaesthesiology, Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER),
Dhanvantri Nagar,
Puducherry.
Pondicherry PONDICHERRY 605006 India |
Phone |
9941032921 |
Fax |
|
Email |
drthooyamani200888@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Priya Rudingwa |
Designation |
Assistant Professor, Anaesthesiology |
Affiliation |
Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER) |
Address |
Department of Anaesthesiology, Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER),
Dhanvantri Nagar,
Puducherry.
Pondicherry PONDICHERRY 605006 India |
Phone |
8903477132 |
Fax |
|
Email |
priyaab8@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
JIPMER |
Address |
Dhanvantri Nagar, Gorimedu, Puducherry, 605006, 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 Thooyamani Ponnusamy |
Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER) |
Department of Anaesthesiology, second floor, Hospital building, Jawaharlal Institute of Postgraduate Medical education and Research, (JIPMER),
Dhanvantri Nagar,
Puducherry. Pondicherry PONDICHERRY |
9941032921
drthooyamani200888@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JIPMER institute Ethics Committee for Human studies |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ASA I&II physical status , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
bougie guided intubation |
To compare success of intubation and laryngeal morbidity in bougieversus wire guided intubation |
Intervention |
wire guided intubation |
To compare success of intubation and laryngeal morbidity in bougie versus wire guided intubation |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Male |
Details |
i. Adults ASA 1-2
ii. Age 20-65 years undergoing surgery under general anesthesia requiring endotracheal intubation
|
|
ExclusionCriteria |
Details |
i. patients planned for awake fibreoptic intubation ,nasal intubation,
ii. Rapid sequence induction.
iii. Patients undergoing surgery in prone position or neck surgery
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare success of intubation and laryngeal morbidity in bougieversus wire guided intubation |
preoperative and within 24 hrs of extubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare hemodynamic stress response and difficulty in railroading the tube in bougie versus wire guided intubation . |
intraoperative only |
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
26/11/2014 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
On the day prior to surgery routine
preanesthetic examination with airway assessment will be done. All patients
will any one or more marker of difficult airway like Modified mallampatti score
2 or more or mild terminal neck restriction will be taken up for the study. After
written informed consent routine premedication will be given. In the operating
theatre after attaching standard ASA monitors patients will be positioned in
sniffing position using a pillow. Following preoxygenation intravenous
induction will be done using fentanyl 2mcg/kg,thiopentone 4-5 mg/kg.
Endotracheal intubation will be facilitated using vecuronium 0.1mg/kg and
following ventilation with 100% oxygen and sevoflurane for 3 minutes
laryngoscopy will be done. On laryngoscopy the Cormack lehane grade will be
recorded and only if it is grade 2 or more the anesthesiologist will intubate
with either bougie or guidewire depending upon the random allocation into
either of the two groups. In the first group (BG) bougie will be passed through
glottis, scope removed and tube railroaded over it. In the second group (WG)
guidewire will be passed through glottis, scope removed and tube railroaded
over it. In both the groups time taken for intubation, hemodynamic parameters
during intubation, successful intubation in first attempt and manipulation needed while railroading the
tube will be noted. If intubation fails with either of the two techniques
videolaryngoscope guided intubation will be done and it will be taken as a
failure. In the post operative period within 12 hours of surgery patients will
be assessed by an ENT surgeon using telelaryngoscopy for any laryngeal
morbidity and questioned regarding any hoarseness of voice or sore throat or
voice changes. |