FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
INTRAMURAL FUNDING 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanvantri Nagar, Gorimedu, Puducherry, 605006, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 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  
Status 
Not Applicable 
 
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.

 
Close