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CTRI Number  CTRI/2020/07/026787 [Registered on: 25/07/2020] Trial Registered Prospectively
Last Modified On: 21/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   We are going to compare 2 techniques for oxygen tube insertion through nose with the help of C mac D video laryngoscope in patients undergoing oral cancer surgeries. 
Scientific Title of Study   A Randomized Controlled Trial Comparing 2 Techniques for Nasotracheal Intubation Using C Mac D Blade Video Laryngoscope in Patients Undergoing Oro Facial Malignancy Surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemlata V Kamat 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College Shree Krishna Hospital 
Address  Department of Anaesthesiology,Pramukh Swami Medical College Shree Krishna Hospital,Gokalnagar,karamsad,Anand-Sojitra road. Anand

Anand
GUJARAT
388325
India 
Phone  9909929422  
Fax    
Email  hemlatavk@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Hemlata V Kamat 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College Shree Krishna Hospital 
Address  Department of Anaesthesiology,Pramukh Swami Medical College Shree Krishna Hospital,Gokalnagar,karamsad,Anand-Sojitra road. Anand

Anand
GUJARAT
388325
India 
Phone  9909929422  
Fax    
Email  hemlatavk@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Kruti Rajeshbhai Jadav 
Designation  PG Student, Department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College Shree Krishna Hospital 
Address  Department of Anaesthesiology,Pramukh Swami Medical College Shree Krishna Hospital,Gokalnagar,karamsad,Anand-Sojitra road. Anand

Anand
GUJARAT
388325
India 
Phone  8690320989  
Fax    
Email  kruti29@gmail.com  
 
Source of Monetary or Material Support  
Pramukh Swami Medical College Shree Krishna Hospital,Gokalnagar,Karamsad,Anand Sojitra road 388325 
 
Primary Sponsor  
Name  Shree krishna hospital 
Address  Anand-Sojitra road,Karamsad,Gujarat. 
Type of Sponsor  Private medical college 
 
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 Hemlata V Kamat  Pramukh Swami Medical College, Shree Krishna hospital, Karamsad  Department of Anesthesiaology, Shree Krishna Hospital, Anand Sojitra road, 388325
Anand
GUJARAT 
9909929422

hemlatavk@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H.M Patel Center for medical care and education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasotracheal intubation using video laryngoscope  Comparing two techniques that is cuff inflation technique and use of magills forceps for nasotracheal intubation using C mac D blade video laryngoscope in patients undergoing oro facial malignancy surgeries 26 patients will be randomly distributed in each group. total 52 patients will be assessed in the study over the period of 1 year since approval  
Comparator Agent  Nasotracheal intubation using video laryngoscope  Comparing two techniques that is cuff inflation technique and use of magills forceps for nasotracheal intubation using C mac D blade video laryngoscope in patients undergoing oro facial malignancy surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients scheduled for orofacial cancer surgeries requiring nasal intubation who fall under following criteria;

1. American Society of Anesthesiologists
(ASA) class I–III
2. Age 18–70 years
3. El Ganzouri risk index (EGRI – total)
between 1 – ≤ 7
will be included in our study.
Difficult airway is graded by EGRI for difficult airway prediction based on seven parameters: - body weight [kg], modified Mallampati class, mouth opening [cm],
Thyromental distance [cm], neck movement [°], prognathism, and history of difficult airway; with a score ranging from 0 to 12 will be used in our study [Table 1]
Table 1: El-Ganzouri risk index Variable Finding
Variable Finding Points
1.Mouth opening(cm) >4 0
<4 1
2.Thyromental distance(cm)
>6.5 0
6.0-6.5 1
<6.0 2
3.Mallampati score I 0
II 1
III 2
4.Neck movement( ⁰ ) >90 0
80-90 1
<80 2
5.Ability to Prognath Yes 0
No 1
6.Body weight ( Kg) <90 0
90-110 1
>110 2
7.History of difficult intubation
None 0
Questionable 1
Definite 2
 
 
ExclusionCriteria 
Details  1. ASA IV patients,
2. Patients with mouth opening <1.5 cm,
3. Patients with hyperkalemia,
4. Patients with history or family history of
malignant hyperthermia,
5. Patients with facial trauma
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
This research project will help to evaluate the two techniques in terms of the time taken in seconds,attempts in number and ease for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery.Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier.  This research project will help to evaluate the two techniques in terms of the time taken in seconds for successful intubation,attempts in number and ease for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery. Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
This research project will help to evaluate the two techniques in terms various complications like hemodynamic changes,desaturation and trauma to teeth and other laryngeal structures for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery.Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier.  This research project will help to evaluate the two techniques in terms various complications like hemodynamic changes,desaturation and trauma to teeth and other laryngeal structures for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery.Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

  The study is planned on patients undergoing oro facial malignancy surgeris comparing 2 techniques for nasotracheal intubation using C mac D blade video laryngoscope after informed consent of the participants and approval of the hospital ethics committe.Patients will be randomized in 2 groups as per the balanced randomization process (WINPEPI software).The two groups will be Group M (use of magill’s forceps) and Group C (use of cuff inflation technique). Nasotracheal intubation (NTI) is the choice of airway management for oro-facial malignancy surgeries in order to enable access to the surgical field. In patients with restricted mouth opening, fibreoptic bronchoscope-guided NTI is the gold standard. Fibreoptic bronchoscope-guided intubation requires training, has a learning curve , is costly (especially for developing world), may not be feasible in the presence of bleeding from a tumor mass, and may not be available everywhere. Other options include blind nasal intubation or nasal intubation guided by a conventional laryngoscope. Blind nasal intubation is a dying art, has a high failure rate, requires expertise, and is not a safer option for cancer patients because of the risk of trauma and bleeding.Recently, video laryngoscopes (VL) have played an important role in airway management in unanticipated difficult or failed endotracheal intubations. Video laryngoscope (Glide scope or C mac D blade VL) can be inserted into oral cavity in patients if mouth opening (>=2.5 cm) is sufficient for insertion of VL.  It is already proven that C-Mac D blade video laryngoscope is better than conventional Macintosh laryngoscope for nasotracheal intubation in patients with difficult airway like oro - facial malignancies. Nasotracheal intubation required for surgical access during oro-facial malignancy surgeries may be challenging due to the presence of, oedema / swelling causing deformities of facial and pharyngeal structures in addition to the other common causes of difficult intubations.ThusVideo laryngoscope(VL)  is indicated in all difficult airway cases – where the mouth opening (inter incisor gap) is restricted to, 1.5-3 cms or in presence of altered anatomy as in malignancy of head face and Neck where conventional laryngoscopy might cause trauma due to alignment of oral -tracheal and pharyngeal  axis for visualisation of glottic aperture. The   VL does not need such alignment   as the camera at the tip provides an image of the glottic aperture   on the screen(Indirect laryngoscopy) 

Successful laryngoscopy using a video laryngoscope does not always guarantee advancement of the tube in the trachea. Correct placement of the tube can be challenging and may require use of different techniques.  Use of Magill’s forceps and Endotracheal tube cuff inflation technique have been described . We plan this study to compare these two techniques during video laryngoscopy to improve the success of nasotracheal intubation in orofacial malignancy surgeries. Glottic view in terms of Cormack-Lehane grade obtained on first view of the monitor, ease of intuba1tion, number of attempts, hemodynamic changes, total duration required for intubation and any other complications like desaturation, mucosal bleeding or dental trauma during the procedure will be the parameters which will be assessed in the studyWe were not able to find such type of a study in the literature comparing the two above mentioned techniques of achieving endotracheal intubation nasally in orofacial malignancies using the video .laryngoscope.Descriptive statistics will be used to depict the profile of participants.

 
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