| CTRI Number |
CTRI/2024/02/062678 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison between 2 videolaryngoscopes, Kingvision and VL3R (Hugemed) in patients posted for electiv surgery under general anaesthesia |
|
Scientific Title of Study
|
A comparative study of Kingvision and VL3R (Hugemed)tm videolaryngoscope for the ease of intubation in adult patients undergoing general anaesthesia for elective surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trisha Kshirsagar |
| Designation |
Second year junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh
Aligarh UTTAR PRADESH 202001 India |
| Phone |
9960072243 |
| Fax |
|
| Email |
trishakshirsagar99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Syed Kamran Habib |
| Designation |
Assistant professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh |
| Address |
Department of anesthesia, Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh, Uttar Pradesh
Aligarh UTTAR PRADESH 202001 India |
| Phone |
9897172780 |
| Fax |
|
| Email |
syedkamranhabib@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Syed Kamran Habib |
| Designation |
Assistant professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh |
| Address |
Department of anesthesia, Jawaharlal Nehru Medical college, Aligarh Muslim University, Aligarh, Uttar Pradesh
Aligarh UTTAR PRADESH 202001 India |
| Phone |
9897172780 |
| Fax |
|
| Email |
syedkamranhabib@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru medical college, Aligarh Muslim University, ALigarh |
|
|
Primary Sponsor
|
| Name |
JNMC hospital, Aligarh |
| Address |
Aligarh |
| 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 |
| Dr Trisha Kshirsagar |
JNMC hospital |
Department of Anaesthesiology, faculty of medicine, Aligarh Muslim University Aligarh UTTAR PRADESH |
9960072243
trishakshirsagar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation using Kingvision Videolaryngoscope |
Patients will be premedicated with IV Inj. Ondansetron 0.1 mg/kg, IV Inj. Fentanyl 1.5 mcg/Kg and IV Inj. Midazolam 30mcg/Kg IV and preoxygenation will be carried out using 100% oxygen using closed circuit with 10 litres of total gas flow. After premedication, Heart rate and Blood pressure will be recorded as prior to intubation values. All patients will be given IV Inj. Propofol 2 mg/kg for induction of anaesthesia until loss of consciousness. IV Inj Succinylcholine 1.5 mg/kg IV as intubating muscle relaxant will be administered after loss of verbal contact and after demonstrable mask ventilation. After adequate muscle relaxation, intubation shall be carried out using Kingvision videolaryngoscope, and parameters will be recorded |
| Intervention |
Intubation using VL3R (Hugemed) Videolaryngoscope |
Investigator will pick the envelope with the name of one videolaryngoscope prior to premedication. Patients will be premedicated and preoxygenation will be carried out using 100% oxygen with 10 litres of total gas flow. Heart rate and Blood pressure will be recorded as prior to intubation values. All patients will be given IV Inj. Propofol 2 mg/kg for induction of anaesthesia until loss of consciousness. IV Inj Succinylcholine 1.5 mg/kg IV as intubating muscle relaxant will be administered after loss of verbal contact and after demonstrable mask ventilation. After adequate muscle relaxation, intubation shall be carried out using VL3R videolaryngoscope and parameters will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Written and well informed consent.
2. ASA grade I-II of either sex.
3. All Mallampatti grades.
4. Age between 18-60 years.
5. Weight between 45-70 Kg.
|
|
| ExclusionCriteria |
| Details |
1.ASA grade III and IV
2. Previous failed intubations
3. Head and neck surgery
4. Pregnancy
5. Inter incisor distance less than 3 cm
6. Risk of gastric regurgitation ( full stomach, hiatus hernia)
7. Raised ICP or cervical spine injury
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time for successful intubation for both the devices |
at first capnograph reading |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in haemodynamic parameters |
pre insertion, immediately post insertion, 3 minutes, 5 minutes, 10 minutes |
| Ease of intubation |
At end of intubation |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Video assisted laryngoscope have a monitor that allows physicians to secure the airway under vision
and additionally capture pictures and videos in real time, Indirect
visualization of the laryngeal inlet provided by the newly designed video assisted laryngoscope facilitates tracheal intubation .
To obtain optimal
visualisation of the glottis, direct laryngoscopy requires alignment of the
oropharyngeal-laryngeal axes. However, duration of intubation and the success
rate for securing the airway by tracheal intubation might have a significant
impact on undesirable events like hypoxia or regurgitation. It can sometimes be
challenging to place an endotracheal tube (ETT) in front of the glottis and
advance it despite good visualization on the monitor, especially when a video
laryngoscope (VL) with a hyper-angulated blade is used. This
phenomena (great view but unable to intubate) is linked to VL blades that are,
unlike the traditional Macintosh blade, hyperangulated. Because of the unique
profile that follows the anatomical shape of the human airway, alignment of the
oropharyngeal-laryngeal axes becomes unnecessary to visualize the glottis.
The new challenge is
now to also bring the tip of the ETT to the level of the glottis, pass the
glottis and advance the tube inside the trachea. Several techniques have been
proposed to meet this challenge; many authors proposed using a stylet to give
the tube the shape of a “hockey stick†to follow the curvature of the video
blade. However, ETT placement is often associated with a prolonged
time for intubation. Additionally, stylet use for video
laryngoscopy has been linked to an increased risk of soft tissue injury of the
upper airway.
The success of a
Videolaryngoscope assisted intubation depends on multiple factors, such as
blade design (acute angled or Macintosh like; channeled or non-channeled);
quality of the image on the monitor, as well as the experience of the intubator
.
Hence we hypothesize from above
findings that for the same reasons mentioned in above studies, perhaps we may
have an alternative device in the form of HugeMed VL3 ,which could be comparable to the king
vision non channeled device in terms of easy and quick intubation time.
Therefore, the present study is
aimed at comparing the VL3 videolaryngoscope and the king vision video
larygnoscope, in terms of airway
management times, performance indices, hemodynamics and complications, if any,
in adult patients scheduled for elective surgery.
|