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
|
|
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
|
|
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. |