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CTRI Number  CTRI/2018/10/015874 [Registered on: 01/10/2018] Trial Registered Prospectively
Last Modified On: 07/09/2022
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   Comparison of Intubation Conditions between three different types of laryngoscopes during rapid sequence induction intubation. 
Scientific Title of Study   Comparision of Intubation Conditions between Airtraq, McGrath Videolaryngoscope and Macintosh under Conditions of Simulated Difficult Airway and Rapid Sequence Induction Intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KRISHNA RAO M 
Designation  MD ANESTHESIOLOGY AND INTENSIVE CARE 
Affiliation  NIZAMs INSTITUTE OF MEDICAL SCIENCES 
Address  DEPT OF ANESTHESIOLOGY AND INTENSIVE CARE,NIMS HOSPITAL,PUNJAGUTTA,HYDERABAD,PINCODE-500032

Hyderabad
ANDHRA PRADESH
500080
India 
Phone    
Fax    
Email  maremanda.krishnarao@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Padmaja Durga 
Designation  professor  
Affiliation  NIZAMs INSTITUTE OF MEDICAL SCIENCES 
Address  department of Anaesthesiology and intensive care,NIMS,Punjagutta,Hyderabad

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9440387299  
Fax    
Email  padmajanims@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Padmaja Durga 
Designation  professor  
Affiliation  NIZAMs INSTITUTE OF MEDICAL SCIENCES 
Address  department of Anaesthesiology and intensive care,NIMS,Punjagutta,Hyderabad

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9440387299  
Fax    
Email  padmajanims@yahoo.com  
 
Source of Monetary or Material Support  
NIZAMS INSTITUE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  NIMS HOSPITAL 
Address  DEPT OF ANESTHESIOLOGY AND INTENSIVE CARE,NIMS,PUNJAGUTTA,HYDERABAD,PINCODE-500032 
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 
KRISHNA RAO M  NIMS   DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARESPECIALITY BLOCK,OT ROOM NUMBER 1 TO 8,PUNJAGUTTA,HYDERABAD,TELANGANA,PINCODE-500032
Hyderabad
ANDHRA PRADESH 		 8790615789

maremanda.krishnarao@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY PATIENTS WHO ARE POSTED FOR ELECTIVE SURGICAL PROCEDURES UNDER GENERAL ANESTHESIA AND WITHOUT ANY COMORBIDITIES AND WITHOUT DIFFICULT AIRWAY PARAMETERS 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AIRTRAQ CHANNELLED VIDEOLARYNGOSCOPY GROUP A  THIS GROUP CONSISTS OF PATIENTS WHO ARE INTUBATED USING AIRTAQ AND ARE CONSISDERED TO BE ONE OF THE INTERVENTIONAL GROUP AND STUDY WILL BE CONDUCTED TILL INTUBATION IS CONSIDERED SUCCESSFUL AS CONFIRMED BY AUSCULTATION,ETCO2 MONITOR 
Comparator Agent  MACINTOSH CONVENTIONAL LARYNGOSCOPY GROUP C  GROUP C INCLUDES PATIENTS WHO ARE INTUBATED USING CONVENTIONAL MACINTOSH LARYNGOSCOPY AND ARE CONSIDERED AS CONTROL GROUP AND STUDY WILL BE CONDUCTED TILL INTUBATION IS CONSIDERED SUCCESSFUL AS CONFIRMED BY AUSCULTATION,ETCO2 MONITOR. 
Intervention  MCGRATH VIDEOLARYNGOSCOPE GROUP GROUP M  THIS GROUP CONSISTS OF PATIENTS WHO ARE INTUBATED USING MCGRATH VIDEOLARYNGOSCOPE AND IS TAKEN AS ONE OF THE INTERVENTIONAL GROUP AND STUDY WILL BE CONDUCTED TILL INTUBATION IS CONSIDERED SUCCESSFUL AS CONFIRMED BY AUSCULTATION,ETCO2 MONITOR 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I or II, Age 18 - 60 years, both sex, patients with normal airway parameters, patients who are posted for elective surgeries under general anaesthesia requiring oral endotracheal intubation 
 
ExclusionCriteria 
Details  Patients with anticipated difficult intubation or difficult mask ventilation, Patients with uncontrolled hypertension, cardiac disorders where hemodynamic responses to intubation may not be tolerated, Patients with poor pulmonary reserve where early desaturation is expected, patients with active secreting adrenal tumors. Patients with large thyroid mass or other neck masses precipitating difficult airway, Patients with BMI > 30 kg/m2, Pediatric age group, pregnant females, C-spine fracture or other cervical disorders with restricted neck movement or unstable cervical spine, faciomaxillary injury or anomalies, abnormalities of airway like burn contractures and cleft lip/palate, TMJ ankyloses, Unwillingness to give consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
We hypothesized that channeled video laryngoscope would provide better visualization in lesser time and safer for use in conditions of simulated difficult airway with rapid sequence induction intubation requiring cricoid pressure as compared to non-channeled video laryngoscope and conventional laryngoscope.  preoperative period to oral endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
this study can be useful for intubating patients with difficult airway parameters in the longrun  preoperative period to oral endotracheal intubation 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="307" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/10/2018 
Date of Study Completion (India) 30/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Li J, Murphy-Lavoie H, Bugas C, Martinez J, Preston C. Complications of emergency intubation with and without paralysis. Am J Emerg Med. 1999;17(2):141-144. doi:10.1016/S0735-6757(99)90046-3. 2. Sagarin MJ, Chiang V, Sakles JC, et al. Rapid sequence intubation for pediatric emergency airway management. Pediatr Emerg Care. 2002;18(6):417-423. doi:10.1097/00006565-200212000-00004. 3. Wong E, Fong YT, Ho KK. Emergency airway management--experience of a tertiary hospital in south-east Asia. Resuscitation. 2004;61(3):349-355. doi:10.1016/j.resuscitation.2004.01.011.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Rapid sequence induction and intubation is known to be associated with airway complications.  Cricoid pressure applied to decrease the risk for aspiration can worsen the glottic view. The increase in time taken for intubation, number of attempts and failure in such situations increases the morbidity. The efficacy and superiority of channeled and non-channeled video laryngoscope over conventional laryngoscopy in such challenging situations has not been evaluated. This study would therefore be conducted to compare the channeled and non-channeled video laryngoscope with conventional laryngoscope in conditions of simulated difficult airway. 
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