| CTRI Number |
CTRI/2020/05/025196 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
05/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of video laryngoscope with routine laryngoscope for nasal intubation. |
|
Scientific Title of Study
|
Comparision of king vision video laryngoscope with macintosh laryngoscope for nasotracheal intubation: A randomized control study. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan R Patil |
| Designation |
Junior Resident |
| Affiliation |
s.nijalingappa medical college bagalkot |
| Address |
Department of Anaesthesia,snmc bagalkot ,navanagar.
Dr Chetan R Patil ,c/o G.D.Nemadi,ward no1,near I B,Guledgudd
Bagalkot
KARNATAKA
587103
India |
| Phone |
8050352467 |
| Fax |
|
| Email |
cpchetanpatil700@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Y Hulakund |
| Designation |
Professor and Head of the department |
| Affiliation |
s.nijalingappa medical college bagalkot |
| Address |
Department of Anaesthesia,snmc bagalkot ,navanagar.
Department of Anaesthesia,snmc bagalkot ,navanagar.
Bagalkot
KARNATAKA
587103
India |
| Phone |
9901098533 |
| Fax |
|
| Email |
hulkunds@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan R Patil |
| Designation |
Junior Resident |
| Affiliation |
s.nijalingappa medical college bagalkot |
| Address |
Department of Anaesthesia,snmc bagalkot ,navanagar.
c/o G.D.Nemadi,ward no1,near I B,Guledgudd
Bagalkot
KARNATAKA
587103
India |
| Phone |
8050352467 |
| Fax |
|
| Email |
cpchetanpatil700@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, H.S.K Hospital, snmc,navanagar, Bagalkot, Karnataka,587103 |
|
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Primary Sponsor
|
| Name |
HSK hospital |
| Address |
H.S.K. Hospital, navanagar, bagalkot. |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chetan R Patil |
HSK Hospital |
Department of Anaesthesia, H.S.K.hospital, snmc, navanagar, Bagalkot
Karnataka 587103
Bagalkot
KARNATAKA |
8050352467
cpchetanpatil700@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC institutional ethics committe on human subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
king vision video laryngoscope for nasotracheal intubation |
king vision video laryngoscope has inbuilt digital video display for view of glottis. |
| Comparator Agent |
macintosh laryngoscope for nasotracheal intubation. |
macintosh laryngoscope is routinely used for intubation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patients posted for elective maxillo facial and ent surgeries under general anaesthesia for nasotracheal intubation.
2.patient belongs to ASA 1 and 2
3.patient with age 20-65years
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal to participate in the study 2.Patients with limited mouth opening of less than 3cm
3.History of documented difficult tracheal intubation
4.Cervical spine instability
5.Chronic suppurative sinusitis
6.Ankylosis of temporomandibular joint
7.Nasal bone fractures.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total intubation time and each time interval as follows,
time A- placement of the nasotracheal tube from selected nostril to oropharynx;
time B- use of devices to view the glottic opening;
time C- nasotracheal tube advanced from oropharynx into trachea and removal of the scope form oral cavity.
|
total time for intubation and each time intervals will be measured during the intubation. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
-To compare scores of modified nasointubation difficulty scale (MNIDS)
-Hemodynamic responses (MAP and HR)
|
-MNIDS score will assessed after successfull intubation
-Hemodynamic responses (MAP and HR) will be assessed before and after intubation |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2020 |
| Date of Study Completion (India) |
29/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Title of the project: COMPARISION OF KING VISION VIDEO LARYNGOSCOPE WITH MACINTOSH LARYNGOSCOPE FOR NASOTRACHEAL INTUBATION: A RANDOMIZED CONTROL STUDY.
Securing the patients airway is essential in general anaesthesia. Airway management problems constitutes about 17 % of anaesthesia closed claims, with difficult intubation being the most common at a rate of 5%. Problems like delayed intubation, misplaced tracheal tube or airway trauma are frequently encountered in outpatient setting and can cause death or brain damage. Video laryngoscopes have been proven useful for intubating patients with difficult airway. With camera and light source on the tip of its blade, the king vision video laryngoscope (KVVL) provides indirect glottis view without needing the align the oral-pharyngeal-tracheal axis. Naso-tracheal intubation is commonly practiced in patients undergoing oro-maxillofacial surgery to provide a secure airway undergoing and good operation field. This allows less tissue damage during laryngoscopy, leading to KVVL’s successful use in awake intubations. Several studies have reported that KVVL provide better glottis views in comparison with other laryngoscopes when used by novice personnel. It remains unclear however whether these results can translate into higher intubation success rates or shorter time to intubation when KVVL is used by experienced anaesthesiologists, hence we conduct this study to compare KVVL and Macintosh laryngoscope for nasotracheal intubation.
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