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CTRI Number  CTRI/2014/01/004275 [Registered on: 02/01/2014] Trial Registered Retrospectively
Last Modified On: 31/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two intubation techniques in patients with cervical collar  
Scientific Title of Study   A comparison of left molar macintosh laryngoscope with gum elastic bougie and Bonfils intubation fiberscope for tracheal intubation in patients with simulated restricted neck mobility 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
114-A-19/11/90/2011-Okh  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anju Gupta 
Designation  earlier specialist at ESI, Now Assistant Professor 
Affiliation  presently at Delhi State Cancer Institute 
Address  ESI Hospital Maa Anand Mayee Marg Okhla Phase I, New Delhi
Department of Anesthesiology and pain Delhi State Cancer Institute Dilshad Garden Delhi-110095
East
DELHI
110020
India 
Phone  9911573371  
Fax  22110505  
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anju Gupta 
Designation  earlier Specialist ESI AND PRESNTLY Assistant Professor at DSCI 
Affiliation  present Delhi State Cancer Institute 
Address  Department of Anesthesiology and Pain Medicine ESI Hospital, Maa Anand Mayee Marg, Okhla Phase I, New Delhi-110020, Delhi, India
Department of Anaesthesiology and Pain Medicine Delhi State Cancer Institute Dilshad Garden, Delhi- 110095
East
DELHI
110020
India 
Phone  9911573371  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anju Gupta 
Designation  earlier Specialist ESI , presently Assistant Professor DSCI 
Affiliation  present ly at Delhi State Cancer Institute 
Address  ESI Hospital, Maa Anand Mayee Marg, Okhla Phase I, New Delhi-110020, Delhi, India
Department of Anesthesiology and Intensive Care Delhi State Cancer Institute Dilshad Garden, Delhi-110095
East
DELHI
110020
India 
Phone  9911573371  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Source of Monetary or Material Support  
ESI Hospital Maa Anandmayee Marg New Delhi 
 
Primary Sponsor  
Name  ESI Hospital  
Address  Maa Anand Mayee Marg, Okhla Phase I, New Delhi-110020, Delhi, India  
Type of Sponsor  Other [Government 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 Anju Gupta  Department of Anesthesiology , ESI Hospital   Operation theater complex,ESI Hospital , Maa Anand Mayee Marg, Okhla Phase I, New Delhi-110020, Delhi, India
South West
DELHI 		 9911573371

dranjugupta2009@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, ESIC Okhla   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  120 ASA physical status I/II patients (18-60 years) scheduled to undergo elective surgical procedures requiring general anesthesia  
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group BIF  patients were intubated with bonfils intubation fiberscope 
Comparator Agent  Group LM  patients intubated with bougie assisted LM approach 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  After ethics committee approval and written informed consent, 120 ASA physical status I/II patients (18-60 years) scheduled to undergo elective surgical procedures requiring general anesthesia were prospectively included in the study. 
 
ExclusionCriteria 
Details  anticipated difficult ventilation or intubation (Mallampatti class 3/4, Mouth opening (MO)< 3cm, thyromental distance < 6.5 cm and sterno mental distance < 12.5 cm), patients with loose molar teeth or increased risk of aspiration, pregnant patients, obese patients (BMI >35) and those with history of difficult intubation were excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to intubation

 		 from beginning of insertion of the device ( bonfils/ laryngoscope) till the End tidal capnograph tracing on the monitor

 
 
Secondary Outcome  
Outcome  TimePoints 
post operative complications:x. Postoperative sore throat (mild, moderate and severe)15, dysphagia or any other respiratory morbidity   1, 6 and 24 hours.  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2012 
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="0"
Months="11"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet submitted 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   conventional intubation techniques require movement of cervical spine to align the three axis to allow direct vision of the vocal cords. cervical collar may reduce the neck movements and mouth opening and makes larynx more anterior, thus making intubating conditions extremly challenging.  Bonfils intubation fiberscope is being increasingly used to facilitate intubation in anticipated and unanticipated difficult airways with good success rates. it has also been shown to markedly improve the intubation success in patients with cervical collar. but this device is expensive , may not be available and has a steep learning curve.
In modern era of technology direct laryngoscopy remains most readily available and fastest means of securing the airway in patients .Left molar approach to direct laryngoscopy improves the glottic view in simulated DA and may help negate the advantage of bonfils intubation fibersope. So ,we hypothetised that bougie assisted left molar approach to laryngoscopy may be a good alternative to Bonfils for intubation in patients with rigid cervical colalr for intubation. 
 
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