| CTRI Number |
CTRI/2014/01/004314 [Registered on: 16/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2015 |
| 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
|
Comparison between two types of tubes used to place a tube in wind pipe (tracheal intubation)for anesthesia through a device called LMA CTrach |
|
Scientific Title of Study
|
A Prospective Randomized Comparative Study of Silicone Wire-Reinforced Tube versus Polyvinyl chloride tube for Tracheal Intubation through LMA CTrachâ„¢ in Patients Undergoing General Anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NANDHINI JOSEPH |
| Designation |
Resident Anesthesiologist |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL, KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
91-9632098540 |
| Fax |
|
| Email |
nandhinijoseph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KRISHNA HM |
| Designation |
Associate Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL, KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
91-9448983314 |
| Fax |
|
| Email |
hmkrishna20032002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRISHNA HM |
| Designation |
Associate Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL, KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
91-9448983314 |
| Fax |
|
| Email |
hmkrishna20032002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MANIPAL UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL |
| Type of Sponsor |
Private medical college |
|
|
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 |
| KRISHNA H M |
KASTURBA HOSPITAL, MANIPAL |
Department of Anesthesiology, CSOT Complex,KASTURBA HOSPITAL MANIPAL, KASTURBA MEDICAL COLLEGE, MANIPAL Udupi KARNATAKA
Udupi
KARNATAKA
Udupi
KARNATAKA |
91-9448983314
hmkrishna20032002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KASTURBA HOSPITAL, MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP POLYVINYLCHLORIDE TUBE: tracheal intubation with polyvinyl chloride tube through LMA CTrach with reverse orientation (curvature of the tracheal tube rotated by 180 degrees to the curvature of LMA CTrach) |
After obtaining an effective airway with LMA CTrach and a grade 1 or 2 view of larynx (entire vocal cords or part of vocal cords plus arytenoids seen), intubation with polyvinyl chloride tube through LMA CTrach will be done |
| Comparator Agent |
GROUP SILICONE TUBE: silicone tube is used for intubation with LMA CTrachâ„¢ |
After obtaining an effective airway with LMA CTrach and a grade 1 or 2 view of larynx (entire vocal cords or part of vocal cords plus arytenoids seen), intubation with silicon tube through LMA CTrach will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender aged between 18- 65 years, belonging to American Society of Anesthesiologists (ASA) physical status 1 and 2, who are scheduled for surgical procedures under general anesthesia requiring tracheal intubation |
|
| ExclusionCriteria |
| Details |
1. Mouth opening less than 2.5cms
2. Patients with anticipated difficult airway
3. Patients with risk of regurgitation and pulmonary aspiration (inadequate fasting, pregnancy, morbid obesity, emergency surgeries requiring rapid sequence induction of anesthesia, history suggestive of acid peptic disease)
4. BMI >35 kg/m2
5. Oral, maxillofacial or laryngeal pathology where LMA CTrachâ„¢ insertion is contraindicated or difficult.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Success rate of intubation including first attempt success rate
2. Ease of intubation |
during tracheal intubation with LMA CTrach (one point assessment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The number and type of manipulations of LMA CTrachâ„¢ done to bring the tracheal tube tip and glottis in alignment during intubation |
At the time of tracheal intubation |
| time taken from the beginning of insertion of tracheal tube till removal of LMA CTrach following successful intubation |
At the time of tracheal intubation |
| The presence or absence of sore throat and hoarseness of voice during first 24 hours following surgery and its severity |
assessed at one point 24 hours following surgery and as reported by the patient at any point of time during these 24 hours |
| Presence of blood or blood stain on LMA CTrachâ„¢ and tracheal tube after its removal |
at the time of removal of LMA and extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/10/2013 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this patient blinded randomized trial 60 patients aged 18-65 years belonging to ASA physical status 1 and 2 will be randomized to be tracheally intubated through LMA CTrach with either PVC tube (Group polyvinylchloride tube) or Silicon tube (Group Silicon tube). The success rate of intubation, first attempt success rates, number of manipulations required during the process of intubation, ease of intubation, time required for successful intubation, incidence and severity of sore throat and hoarseness of voice will be observed and compared between the two groups. |