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CTRI Number  CTRI/2018/10/015947 [Registered on: 08/10/2018] Trial Registered Prospectively
Last Modified On: 07/10/2018
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 of two different endotracheal tubes for intubation through King-Vision Video Laryngoscope in patient with Cervical spine instability  
Scientific Title of Study   Tracheal intubation with King vision video laryngoscope in patients with cervical spine instability – Comparison of straight versus curved reinforced endotracheal tubes. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Patel 
Designation  Resident Doctor 
Affiliation  Maharaja Sayajirao University, Vadodara 
Address  Department of Anesthesiology, Medical college Baroda, Maharaja Sayajirao University, Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9601745688  
Fax    
Email  patel.nisha35@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Devyani Desai 
Designation  Associate Professor 
Affiliation  Maharaja Sayajirao University, Vadodara 
Address  Department of Anesthesiology, Medical college Baroda, Maharaja Sayajirao University, Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nisha Patel 
Designation  Resident Doctor 
Affiliation  Maharaja Sayajirao University, Vadodara 
Address  Department of Anesthesiology, Medical college Baroda, Maharaja Sayajirao University, Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9601745688  
Fax    
Email  patel.nisha35@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Medical College Baroda, Maharaja Sayaji Rao University, Raopura, Vadodara - 390001 
 
Primary Sponsor  
Name  Medical College Baroda 
Address  Department of Anesthesiology, Medical College Baroda, Maharaja Sayaji Rao University, Raopura, Vadodara - 390001 
Type of Sponsor  Government 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 
Nisha Patel  Medical College Baroda  Department of Anesthesiology, Medical College Baroda, Maharaja Sayajrao University, Vadodara
Vadodara
GUJARAT 
9601745688

patel.nisha35@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee for Human research, Medical college and SSG Hospital, Baroda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M509||Cervical disc disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curved Re-inforced Endotracheal Tube  Curved Re-inforced Endotracheal Tube(Rusch). 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Straight Re-inforced Endotracheal Tube  Straight Reinforced endotracheal tube(Rusch). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate in study group
2.All patients placed scheduled for elective cervical spine surgery
3.Age: 18- 60 years
4.Either sex
5.ASA I and II
6.BMI less than 30 kg/m2
7.Mallampatti Grade: I and II
8.Mouth opening more than 20mm 
 
ExclusionCriteria 
Details  1.Thyromental distance less than 6cm
2.Sterno-mental distance less than 12 cm
3.Oropharyngeal pathology
4.Patients with the h/o difficult intubation in the past
5.Pregnant patients
6.Known case of GERD 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ease and success of intubation.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
No. of attempts of tube insertion and incidence of impingement of tube with the arytenoids and optimization manoeuvres required for intubation,and complications.  1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/10/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study will be performed to compare ease and success rate of intubation with the straight and curved reinforced tubes using King vision video laryngoscope for tracheal intubation in patients to be operated for cervical spine instability admitted at SSG Hospital. We will do time-bound study, taking 5 cases per month, minimum 60 cases (30 cases in each group). After fulfilling all inclusion criteria, patient will be allotted to group, either Group S (straight reinforced endotracheal tube) or Group C (curved reinforced endotracheal tube) using envelope method. Thorough pre-anesthetic evaluation and informed written consent, premedication will be given. After 3 minutes of pre-oxygenation, patient will be induced. Post – induction, the King vision videolaryngoscope with loaded ET (either straight or curved) will be advanced from the centre of the tongue towards glottis by viewing on the screen of the monitor, and simultaneously with the view of glottis on monitor. Intubation will be attempted only if an optimal glottis view, with POGO score of ≥75% will be obtained. Maximum 2 attempts with the selected reinforced endotracheal tubes will be allowed. If it is not possible to direct the ETT toward the glottis, optimization manoeuvres like external laryngeal pressure, manipulation of King vision blade or use of bougie will be attempted to direct the ETT into the glottis after obtaining an optimal glottis view and will be assessed on a score of 0 to 2. Failed intubation will be defined as an attempt in which patient could not be intubated even with optimization manoeuvres or > 120 secs required to perform the procedures. Ease of intubation will be assessed and scored as good, satisfactory or poor. In case of failure, the patient will be intubated with standard PVC endotracheal tubes by using Macintosh laryngoscope after maintaining the manual in line stabilization and will be excluded from the study. Following parameters will be monitored and compared.

1. Time for intubation: Time in seconds taken from obtaining an optimal glottis view (75%) to first wave of Capnogram.

2. Percentage of glottic opening (POGO) score: A POGO score of 100% denotes visualization of the entire glottis from the anterior commissure of the vocal cords to the inter-arytenoid notch. If none of the glottic opening were visualized (even the inter-arytenoid notch is not seen), then the POGO score would be 0%.

3. No. of attempts of tube insertion: maximum two.

4. Incidence of impingement of tube with the arytenoids.

5. Optimization manoeuvres required for intubation like external laryngeal pressure or manipulation of King-vision blade or use of bougie.

6. Ease of intubation: Scored as good, satisfactory and poor.

7. Vital parameters: Hemodynamic parameters like heart rate, mean arterial pressure, SpO2 and ETCO2 to be noted at the time of induction, at time of intubation, after 2 minutes and 5 minutes.

8.   Complications like Fail to intubate (unable to perform endotracheal intubation using King Vision Video Laryngoscope in 2 attempts), Minor tongue/ lip/ dental trauma, Oesophageal intubation will be also monitored.

Data will be collected from multipara monitor and monitoring screen of King vision video laryngoscope and will be analyzed using Medcalc software. Descriptive statistics values will be expressed as mean ± SD (standard deviation) and p-value <0.05 will be considered as significant. Unpaired Student‘t’ test will be used for quantitative data and Chi square test will be used for the qualitative data like no of attempts, no of optimization manoeuvres and ease of intubation using Medcalc software.

The intubation is expected to be easy and with higher success rate using curved reinforced tube than straight reinforced tube.

 
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