A study to see the utility of Baska mask (airway device) with regards to management of airway during general anaesthesia
- Conditions
- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, Patients with ASA status I-II, More than 18 years of age with Mallampati class I-II having a mouth opening more than 3 cm BMI less than 30 kg/m2,
- Registration Number
- CTRI/2018/04/013402
- Lead Sponsor
- TRAC
- Brief Summary
**Introduction and Background:**
Avariety of devices are available for securing the airway during conduct ofgeneral anaesthesia, the gold standard being the endotracheal tube. However, itmay be replaced with less invasive devices to reduces complications such asglottis trauma, ischemia of the tracheal mucosa with subsequent stenosis tolist a few; provided this does not compromise the patient safety.Baska mask isa novel airway device with a self sealing variable pressure cuff whichincreases proportionately with increasing airway pressure during positivepressure ventilation. It has an insertion tab for manually curving the mask foreasy insertion. The large distal aperture locates at the upper oesophagus andopens into the sump cavity for easy drainage of gastric fluid thus minimisingthe risk of aspiration. The advanced airway opening provides superior patencyof seal and increased protection against gastric overflow.
Dr.Archie Bain developed the laryngeal mask airway in 1982 at royal Londonhospital as a modification of the Goldman dental mask. Supraglottic airwaydevices in comparison to endotracheal tube reduce the stress response whichoccurs with laryngoscopy and intubation reduces requirement of anaestheticagents for airway tolerance, neuromuscular blockade not always necessary forinsertion, easier to insert, have a lower incidence of sore throat, it can beeasily inserted in patient with cervical spine injury.
Baskamask is a novel airway device which has a self sealing variable pressure cuffwhich increases proportionately with increasing airway pressure during positivepressure ventilation. The cuff is continuous with the airway channel and getsinflated with positive pressure ventilation. It has an insertion tab formanually curving the mask for easy insertion. It has a large distal aperturewhich locates at the upper oesophagus and has a sump cavity for easy drainageof gastric fluid thus minimizing aspiration risk. The dorsal surface is made ina way that it directs the oropharyngeal secretions towards the side channel towhich suction can be attached. The tube also has a built in bite block. The proximal end has loops which help infixation of the mask.
**Aim:**
The aim of this study is to see the utility ofBaska mask with regards to management of airway during general anaesthesia.
**Study design:**
It will bea Prospectiveobservational study
**Patients and methods:**
Patients undergoingsurgeries in Tata Memorial Centre over duration of one year will be enrolled inthe study. All patients fulfilling the inclusion criteria and after obtaininginformed written consent, posted for elective surgery under anaesthesia will beincluded in the study.
Inclusion criteria: Participatingpatients should satisfy the following:
1. ASA status I-II
2. >18 years of age
3. Mallampati class I-II
4. Having a mouth opening > 3 cm
5. BMI < 30 kg/m2
6. Elective surface surgery of short durationrequiring general anaesthesia.
Exclusion criteria:
1. Patients with anticipated difficult airway
2. Current or recent sore throat
3. Gastro-oesophageal reflux disease
4. Cervical spine disease
5. Pregnancy
6. Dysphonia or dysphagia**.**
Samplesize:
The literature regarding the use of Baska mask isscarce with first attempt success rates ranging from 72-88%. To detect a firstattempt success rate of 80% with 8% precision (range 72% to 88%) at 95%confidence, we will need to study 97 patients. Therefore, we will include 100patients to allow for protocol violation, lack of data, etc. This study will bedone over a period of 12 months.
Methodology:
This willbe a prospective observational. After obtaining Ethics committee approval andwritten informed consent, 100patients will be enrolled.
**Participating patients should satisfyfollowing criteria:**
1. ASA status I-II
2. >18 years of age
3. Mallampati class I-II
4. Having a mouth opening > 3 cm
5. BMI < 30 kg/m2
6. Elective surface surgery of short durationrequiring general anaesthesia.
**Following patients will be excluded:**
1. Patients with anticipated difficult airway
2. Current or recent sore throat
3. Gastro-esophagealreflux disease
4. Cervical spine disease
5. Pregnancy
**6.**Dysphonia or dysphagia**.**
After obtaining informed consent from thepatients, an appropriate sized Baska mask will be used according to therecommendation of the manufacturer.
Anaesthesiawill be induced with fentanyl 2mcg/kg and propofol 2 mg/kg. Intermediate actingmuscle relaxant will be used for muscle paralysis. Hemodynamic parameters- HR,SBP, DBP, MAP, will be measured non-invasively at following intervals: beforeinduction of anaesthesia and every minute up to 5 minutes after induction ofanaesthesia. Anaesthesia will be maintained with Sevoflurane/Isoflurane and N2Oin 40% oxygen. Tidal volume will be adjusted to keep end-tidal-CO2concentration between 30-35 mm Hg. The primary end point of the study will be first attempt success rateof insertion of baska mask.
Variables measured will be:
1. First attempt success rate of insertion of Baskamask.
2. Overall success rate of insertion of Baska mask.
3. Number of attempts needed for insertion.
4. Time required to secure the airway.
5. Magnitude of hemodynamic response frombaseline to up to 5 minutes after insertion.
6. Adequacy of airway sealing pressure (no leakat 20 cm H2O airway peak pressure or tidal volume 8 ml/kg).
7. Stability of device intra-operatively. Anydisplacement or need to reinsert the device intra-operatively.
8. Need to change over to endotrachealintubation.
9. Presence of sore throat 1 h our after removalof device.
10.Presence of dysphagia (after giving a fewsips of water) 1 hour after removal of device.
11.Any adverse events such as bronchospasm, Laryngospasmor desaturation (<92%) aspiration, regurgitation of gastric contents.
**Insertion and positioning**: A singleoperator after achieving the competency in insertion of the airway device willinsert the airway in all patients. Airway insertion time will be recorded usinga stop watch. Recording will start when the device will be inserted in the patient’smouth and stop when an adequate airway (as described above) is obtained. Thenumber of attempts required to correctly position the device will be recorded,along with the size used. Once the device is optimally positioned, its positionwill not be altered unless clinically indicated.
Laryngospasm,if occurs will be recorded.
**Airway sealing pressure:** Afteroptimally positioning the device, airway sealing pressure will be measured byclosing the expiratory valve of the circle system at a fixed gas flow andnoting the airway pressure at which the dial on the aneroid manometer reachesequilibrium.
**Degree of irritation:** One hourpost-operatively, patients will be asked about presence of sore throat ordysphagia.
**Ethical Considerations:**
The studywill be initiated after obtaining the approval of The Institutional EthicsCommittee. Written informed consent will be taken from all participatingpatients.
**Statistical analysis**:
Since thisis an observational study, we will use descriptive analysis to describe successrate. A student’s t test and Chi square test will be used for describingadverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1.ASA status I-II 2.>18 years of age 3.Mallampati class I-II 4.Having a mouth opening > 3 cm 5.BMI < 30 kg/m2 6.Elective surface surgery of short duration requiring general anaesthesia.
1.Patients with anticipated difficult airway 2.Current or recent sore throat 3.Gastro-esophagealreflux disease 4.Cervical spine disease 5.Pregnancy 6.Dysphonia or dysphagia.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point of the study will be first attempt success rate of insertion of baska mask The primary end point of the study will be first attempt success rate of insertion of baska mask
- Secondary Outcome Measures
Name Time Method Number of attempts needed for insertion At the time of insertion
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Kailash SharmaPrincipal investigator02224177044rashmikailashsharma@yahoo.co.in