A study on use of videolaryngoscope and conventional laryngoscope for insertion of endotracheal tube in mannequin by medical students
- Conditions
- MBBS interns posted in department of Anaesthesiology who will participate in the study on mannequins
- Registration Number
- CTRI/2017/11/010491
- Lead Sponsor
- Ramaiah Medical College and Hospitals
- Brief Summary
**1.****Departments involved:Anaesthesiology**
**2.****Summary of the proposed study ( 250 words)**
Airwaymanagement is the prime responsibility of the anaesthesiologist. Videolaryngoscopes are now a part of airway management armentarium. King visionlaryngoscope is one of the most cost effective video laryngoscope available.The learning curve for successful use of video laryngoscope is short compared todirect laryngoscopy. In this study we will be comparing video laryngoscope withdirect laryngoscope when used by airway novices.
The study design will be a prospective,randomized, controlled study which will be conducted in Ramaiah Medical CollegeAdvanced learning center simulation lab. To evaluate the difference in efficacy between directlaryngoscopy(DL) and video laryngoscope(VL),we will randomly assign 106 medical students to either of 2 intubation groupsof 53 each.
GROUP DL - DIRECT LARYNGOSCOPE
GROUPVL – VIDEO LARYNGOSCOPE
All participantswill be briefed for 5-minute instructions on DL and VL that included anintroduction to the equipment and demonstrated both a misplacement of the ETTin the esophagus and the correct placement in the trachea. Then, the studentswill oriented on the mannequin so that they could visualize the correctanatomic landmarks and the ideal insertion path of the ETT. The trial will end when the student eitherthe participant successfully passes the ETT into the trachea or the 300 secondtime limit reached.
The participantsthen will crossover and perform laryngoscopy and intubation using the otherdevice. The same parameters will be measured.To assess time for successfulendotracheal intubation. We will also record the esophageal intubations, firstattempt intubations and excessive pressure on the maxillary incisor teeth. Wealso determine the overall endotracheal intubation success rate of the twogroups. The comparison of ease of usebetween the devices will be scored.
3. **Any work already done**– A pilot study has already been done.
**4.****Justification or Need for the study :**
The purpose of this study was to determinewhether video laryngoscopy (VL) provides any advantage over direct laryngoscopy(DL) in first-attempt intubations by inexperienced medical students insimulation. Our hypothesis is by using VL the time taken for successful firstattempt endotracheal intubation is considerably faster. Also it might also providegood intubating conditions by reducing the incidence of esophageal intubation(EI), excess application of pressure on the maxillary incisor teeth (EMP). Thereare no studies on the use of VL in comparison with DL in airway novices
**5.** **Aims &Objectives:**
1. Compare the video laryngoscope with thetraditional Macintosh laryngoscope in identifying the time forsuccessful endotracheal intubation.
2. Secondary outcome measures includes theincidence of esophageal intubation (EI), excess application of pressure on themaxillary incisor teeth (EMP), and first-time success rate.
3. Ease of use in using direct larygoscopy versus video laryngoscopy .
**6.** **Hypotheses (ifapplicable):**
**7.** **Review ofliterature : (within 500 words)**
1. HannesPrescher et. al.(1) Conducted a study to determine whether video laryngoscopy provides any advantage over direct laryngoscopy in first-attempt intubations. This was a controlled, randomized study of 120 medical students. Students were randomly assigned to either of 2 intubation groups, which used DL (n=64) VL (n=56) with the Karl Storz C-MAC video laryngoscope. Each student attempted 1 endotracheal intubation on a Laerdal Airway Management Trainer. The primary outcome measure was the time for successful endotracheal intubation. Secondary outcome measures included the incidence of esophageal intubation (EI), excess application of pressure on the maxillary incisor teeth (EMP), and first-time success rate. Mean time for endotracheal intubation was significantly faster in the VL group than in the DL group (101 ± 83 seconds vs. 180 ± 102.5 seconds; P˂0.001). In the VL group, 3.6% of the students committed an EI versus 56.3% in the DL group (P˂0.001). No significant difference was found in the incidence of EMP: 51.8% in the VL group versus 57.8% in the DL group (P=0.508). For medical students with little or no endotracheal intubation experience, VL facilitates success and decreases the number of EIs, at least in a simulated environment
2. J. McElwain et.al.(2) conducted a study to compare the C-MAC with Macintosh, Glidescope and Airtraq laryngoscopes in easy and simulated difï¬cult laryngoscopy. Thirty-one experienced anaesthetists performed tracheal intubation in an easy and difï¬cult laryngoscopy scenario. The duration of intubation attempts, success rates, number of intubation attempts and of optimisationmanoeuvres, the severity of dental compression, and difï¬culty of device use were recorded. In easy laryngoscopy, the duration of tracheal intubation attempts were similar with the C-MAC, Macintosh and Airtraq laryngoscopes; the Glidescope performed less well. The C-MAC and Airtraq provided the best glottic views, but the C-MAC was rated as the easiest device to use. In difï¬cult laryngo- scopy the C-MAC demonstrated the shortest tracheal intubation times. The Airtraq provided the best glottic view, with the Macintosh providing the worst view. The C-MAC was the easiest device to use.
3. Frank Herbstreit et. al.(3) Conducted a prospective assessement in medical students intubation skills acquired by intubation attempts in adult anesthetized patients during a 60-hour clinical course in a randomized fashion, either a conventional Macintosh blade laryngoscope or a videolaryngoscope. Skills were measured before and after the course in a standardized fashion (METI Emergency Care Simulator) using a conventional laryngoscope. All 1-semester medical students (n 93) were enrolled. The students’ performance did not signiï¬cantly differ between groups before the course. After the course, students trained with the videolaryngoscope had an intubation success rate on a manikin 19% higher (95% CI 1.1%–35.3%; P < 0.001) and intubated 11 seconds faster (95% CI 4–18) when compared with those trained using a conventional laryngoscope. The incidence of difï¬cult (manikin) laryngoscopy was less frequent in the group trained with the videolaryngoscope (8% vs 34%; P = 0.005).
4. K. J. Howard-Quijano et.al.(4) conducted a study to determine if video-assisted laryngoscopy improves the effectiveness of tracheal intubation training. In this prospective, randomized, crossover study, 37 novices with<6 prior intubation attempts were randomized into two groups, video-assisted followed by traditional instruction (Group V/T) and traditional instruction followed by video-assisted instruction (Group T/V). Novices performed intubations on three patients, switched groups, and performed three more intubations. During video-assisted instruction, novices were successful at 69% of their intubation attempts whereas those trained during the non-video-assisted portion were successful in 55% of their attempts (P<0.04). Oesophageal intubations occurred in 3% of video-assisted intubation attempts and in 17% of traditional attempts (P<0.01).They concluded the study by stating improved rate of successful intubation and the decreased rate of oesophageal intubation support the use of video laryngoscopy for tracheal intubation training.
**V.****Materials andMethods**
The study design will be a prospectiverandomized studyof 106 students who are doing internship. This study will be conducted inRamaiah Medical College Advanced learning center simulation lab. To evaluate the difference in efficacybetween DL and VL, we will randomly assign 106 medical students to either of 2intubation groups of 53 each.
GROUP-1-DL - DIRECT LARYNGOSCOPE
GROUP-2- VL – VIDEO LARYNGOSCOPE
INCLUSION CRITERIA
(1) All interns posted in anaesthesiology.
EXCLUSIONCRITRERIA
(1) Interns who have performed >5 or more laryngoscopy/intubation.
All participants will be briefed for 5-minute instructions on DL and VLthat included an introduction to the equipment and demonstrated both amisplacement of the ETT in the esophagus and the correct placement in thetrachea. Then, the students will oriented on the mannequin so that they couldvisualize the correct anatomic landmarks and the ideal insertion path of theETT. The orientation will be given byanaesthetist with extensive clinical intubation experience. Their will not be any trial runs by the participants.After the training, each of the students will attempt one endotrachealintubation by using conventional direct laryngoscope using Macintosh size 3blade or video laryngoscope on the mannequin. They will be timed frominitiation of hand placement on the laryngoscope to successful intubation witha 7.0 ETT, as evidenced by visible lung excursion. If students perform anesophageal intubation, as indicated by inflation of the stomach pouch, thiswill be counted as 1 EI and students will be prompted to start again. We willrecord the number of EI during the study time. A maximum time limit of 300seconds (5 minutes) will be set for all students. The trial will end when thestudent either the participant successfully passes the ETT into the trachea orthe 300 second time limit reached.
Failure toachieve endotracheal intubation by that point will be defined as an“unsuccessful†intubation trial. Themannequin gives an audible indication to signal tooth damage when excessivepressure on the upper incisors is applied during laryngoscopy and this will berecorded. The study will have a research assistant help prepare the ETT and thestylet, inflate the ETT cuff after intubation and begin mechanical ventilationwith an Ambu bag valve mask. This is to ensure that the intubation time reflectsonly the participant’s ability to obtain proper visualization and to pass theETT, the two pivotal steps of the intubation procedure . The research assistantwill be a simulation technician who has specifically trained to perform thesetasks and in no other way interfered with the performance of the study.
The participantsthen will crossover and perform laryngoscopy and intubation using the otherdevice. The same parameters will be measured.
The time for successful endotracheal intubation will be noted. We willalso record the esophageal intubations, first attempt intubations and excessivepressure on the maxillary incisor teeth. We also determine the overallendotracheal intubation success rate of the two groups. The comparison of ease of use between the deviceswill be scored.
**SAMPLE SIZE**
To calculate therequired number of participants to perform the study we considered the previous study conducted by Prescher etal. who observed that time taken for intubation with DL scopy was found to be118 ± 67 seconds; whereas with video laryngoscope using C-MAC it was found to be 81.9 ± 57.1 seconds. In thepresent study we are expecting the similar results with a power of 80 % ,confidence level of 95 % and considering 30 seconds difference as clinical significant in one tilt test between the two groups. Thestudy requires a total of 106 subjects with 53 subjects in each group. Theparticipants will be allotted into groups by computer generated random numbertable.
**STATISTICAL METHODS**
Descriptivestatistics of time taken for successful endotracheal intubation will beanalysed and summarized in terms of mean with SD, independent‘t’ test would beused to compare time between the two groups.
VI. Ethical considerations and methods to addressissues: NOVII. Implications of the study Innear future video laryngoscope might replace direct laryngoscopes as thelearning curve is short.
VIII. Budget and proposed funding source: Selffunded IX. References1. Hannes Preacher, David E. Biffar, Laura E. Meinke, JohnE. Jarred, Aubrey J. Brooks, Allan J. Hamilton. Video-guided Versus DirectLaryngoscopy: Considerations For Using Simulation To Teach InexperiencedMedical Students. The Society for Modeling and Simulation International,Simulation Series. Vol. 46; 10.ed: 2014; 253-258.
2. J. McElwain, M.A. Malik, B.H. Harte, N.M.Flynn, and J.G. Laffey.Comparison of the C-MAC videolaryngoscope with the Macintosh, Glidescope, and Airtraqlaryngoscopes in easy and difï¬cult laryngoscopy scenarios in manikins. Anaesthesia 2010 ; 65: 483–489
3. Frank Herbstreit, Philipp Fassbender,HelgeHaberl, Clemens Kehren, and Ju¨rgen Peters .Learning EndotrachealIntubation Using a Novel Videolaryngoscope Improves Intubation Skills ofMedical Students . Anesth Analg 2011;113: 586–90
4. K. J. Howard-Quijano , Y. M. Huang , R.Matevosian , M. B. Kaplan and R. H. Steadman1 . Video-assisted instructionimproves the success rate for tracheal intubation by novices. Br J Anaesth 2008; 101: 568–72
X. Enclosures:Case record form, informed consent, Questionnaire(if any)
- Study proforma
- Informed consent form
**STUDY PROFORMA**
NAME:
AGE: SEX: Roll no
1. EXPERIENCE IN AIRWAY MANAGEMENT: YES/NO
If yes
A. Seenlaryngoscopy and intubation YES/NO
If yes number
B. Assisted laryngoscopy and intubation YES/NO
If yes number
2. PERFORMED ANY AIRWAY MANAGEMENT: YES/NO
(If yes number done)
1. Laryngoscopy 1 2 3 4 5
2. LMA insertion 1 2 3 4 5
AIRWAY MANAGEMENT: DIRECTLARYNGOSCOPY/ VIDEO LARYNGOSCOPY
| | | | | |
| --- | --- | --- | --- | --- |
|Attempt
1
2
3
4
|Time in seconds
|OESOPHAGEAL INTUBATION(EI)
|EXCESS APPLICATION OF PRESSURE ON MAXILLARY TEETH(EMP)
|First attempt intubation
Ease of use ofvideo laryngoscope in comparison tomactintosh blade (please tick)
( ) Difficult
( ) Easy
( ) Same
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 106
All interns posted in department of anaesthesiology.
MBBS interns who have performed 5 or more laryngoscopy or intubations MBBS interns not willing to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The trial will end when the student either the participant successfully passes the ETT into the trachea or the 300 second time limit reached. 300 seconds
- Secondary Outcome Measures
Name Time Method 1 Esophageal intubation 2 Excessive pressure on teeth
Trial Locations
- Locations (1)
MS Ramaiah Medical college Advanced learning center
🇮🇳Bangalore, KARNATAKA, India
MS Ramaiah Medical college Advanced learning center🇮🇳Bangalore, KARNATAKA, IndiaDr Balaji TPrincipal investigator9886866382blj_t@yahoo.co.in