A STUDY COMPARING CONVENTIONAL MACINTOSH LARYNGOSCOPE WITH VIDEOLARYNGOSCOPE FOR NASOTRACHEAL INTUBATION
- Conditions
- Age group of 18-60 years of age both sexes.American Society of Anaesthesiologist(ASA) grade I,II and III posted for elective surgery requiring nasotracheal intubationMedical and Surgical,
- Registration Number
- CTRI/2023/09/057172
- Lead Sponsor
- Bharati Hospital and Research Centre
- Brief Summary
Ethical approval obtained for the study from the Ethics Committee.The patients will be informed about the study in a language they fully comprehend.They will be given patient information sheet and will be enrolled in the study after taking a written informed consent.
The participants will be allocated to one of the two groups by computer generated randomized controlled trial.
The consented patients of MP I and II of 18-60 yrs of both the genders scheduled for elective surgery requiring nasotracheal intubation under general anaesthesia will be selected,laryngeal view is to be assessed by Modified Cormack Lehane’s Score (MCLS)with Macintosh Laryngoscope and Percentage Of Glottis Opening (POGO)score with Tuoren Kingtaek videolaryngoscope.
Percentage of Glottis Opening (POGO) scores.
Description. POGO Scores (%)
Full view of the cords. 100
Most of the larynx visible 50–75
Only posterior part of the larynx visible 25-50
Only epiglottis visible 0
Epiglottis and glottis not visible.
Patients will be admitted in the ward as inpatients and routine investigations and nasal patency along with test for deviated nasal septum will be done. The more patent nostril will be mentioned in the assessment.
Patients will be allocated on the morning of surgery to either the control group (NTI using standard Macintosh blade) or intervention group (NTI using Tuoren Kingteak VL). Randomization will be carried out as per a computer generated block randomization sequence with allocation concealment using opaque sealed envelopes. It will be done by a senior faculty, not part of the study.
PREMEDICATIONAll patients will be premedicated with antisialogogue Inj. Glycopyrrolate 10μg/kg. Topical preparation of the nasal cavity by instilling Xylometazoline 0.05% drops twice into each nostril will be done in both groups.
On arrival into the operating room patient’s baseline parameters such as heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure and SpO2 will be recorded. Patient will be monitored with pulse oximetry, NIBP and ECG. I.V Line to be secured.
Inj. Midazolam 0.02mg/kg and Inj. Fentanyl 2μg/kg will be given to the patient. Patient will be preoxygenated with 100 % oxygen for 3 minutes.
INDUCTIONPatient will be induced with Inj. Propofol 2mg/kg .
MUSCLE RELAXANTInj.Atracurium 0.5 mg/kg will be used and patients will be ventilated for 3 minutes
INTUBATIONAll patients will be intubated with their heads in sniffing position. The appropriate flexometallic endotracheal tube of the size 7/7.5/8.0/8.5 as per discretion of the intubating anaesthesiologist will be chosen and introduced into the most patent nostril till it lies in the oropharynx.
In both the groups, the use of Magill’s forceps will be left to the discretion of the intubating anesthesiologists and this data will be captured. A maximum of three intubation attempts with the study device will be permitted. Removal and reinsertion of the laryngoscope into the mouth will be considered an attempt.
Mask ventilation will be allowed between attempts if the attending anesthesiologist deemed it necessary or if the SpO2 drops below 95% during intubation
The time from insertion of laryngoscope to appearance 1st square wave form of capnograph will be defined as time to successful intubation.
Need for external laryngeal manipulation and use of Magill’s forceps will be recorded. Haemodynamic parameters (HR,MAP) will be recorded from 1,2, 5, 8& 10 mins from intubation.
All outcomes will be recorded by an independent observer in the respective operation theatre, who is not a part of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 74
- INCLUSION CRITERIA: 1.Patients who are undergoing elective surgery requiring nasotracheal intubation under GA 2.MP-I and MP-II patients 3.ASA-I and ASA-II patients.
- 4.Age group of 18-60 years.
- EXCLUSION CRITERIA: 1.Refusal of consent.
- 2.Anticipated difficult airway 3.Emergency surgery 4.Those at increased risk of aspiration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome measured are: Time points are: | T0- first observation when patient is bought to operation theatre. | T induction- observation at the time General anesthesia induction | T intubation- observation at the time of intubation | T1,T2,T4,T8,T10 are observation at 1,2,4,8,10 minutes respectively after intubation. 1. Time required for intubation, which is considered as the time from insertion of laryngoscope to appearance 1st square wave form of capnograph will be defined as time to successful intubation. Time points are: | T0- first observation when patient is bought to operation theatre. | T induction- observation at the time General anesthesia induction | T intubation- observation at the time of intubation | T1,T2,T4,T8,T10 are observation at 1,2,4,8,10 minutes respectively after intubation. 5. Attempts required for intubation. Time points are: | T0- first observation when patient is bought to operation theatre. | T induction- observation at the time General anesthesia induction | T intubation- observation at the time of intubation | T1,T2,T4,T8,T10 are observation at 1,2,4,8,10 minutes respectively after intubation. 2. Heart Rate Time points are: | T0- first observation when patient is bought to operation theatre. | T induction- observation at the time General anesthesia induction | T intubation- observation at the time of intubation | T1,T2,T4,T8,T10 are observation at 1,2,4,8,10 minutes respectively after intubation. 3. Blood Pressure Time points are: | T0- first observation when patient is bought to operation theatre. | T induction- observation at the time General anesthesia induction | T intubation- observation at the time of intubation | T1,T2,T4,T8,T10 are observation at 1,2,4,8,10 minutes respectively after intubation. 4. Need for External maneuvers Time points are: | T0- first observation when patient is bought to operation theatre. | T induction- observation at the time General anesthesia induction | T intubation- observation at the time of intubation | T1,T2,T4,T8,T10 are observation at 1,2,4,8,10 minutes respectively after intubation.
- Secondary Outcome Measures
Name Time Method Need for external laryngeal manipulation and use of Magill’s forceps will be recorded. Haemodynamic parameters (HR,MAP) will be recorded from 1,2, 5, 8& 10 mins from intubation.
Trial Locations
- Locations (1)
Major OT Complex, Bharati Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Major OT Complex, Bharati Hospital and Research Centre🇮🇳Pune, MAHARASHTRA, IndiaDrAchanya SankarPrincipal investigator8547218810achupillai@hotmail.com