Airway Management
Conditions
Keywords
Airway management, LMA, Cricoid pressure, Paratracheal pressure, Supraglottic airway device
Brief summary
The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.
Interventions
OTHERCricoid pressure
Cricoid pressure will be applied during LMA ProSeal insertion.
Pratracheal pressure will be applied during LMA ProSeal insertion.
Sponsors
Karaman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
patients, care providers, investigator and outcome assessors will be blinded.
Intervention model description
There are two groups; 1. Experimental Group: Group P; paratracheal compression will be applied during LMA ProSeal insertion. 2. Sham Comparator: Group C; cricoid compression will be applied during LMA ProSeal insertion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.
Exclusion criteria
* with cervical spine disease * expected difficult airway * upper airway abnormalities * body mass index (BMI) more than 35 kg/m2 * high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation) * postoperative ventilator care * surgeries requiring positions other than supine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of insertion | During intubation procedure | The time required for placement will be defined as the time from receipt of the LMA ProSeal to detection of the square waveform on capnography and will be calculated by summing the time taken for each attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensation of resistance during inserting of LMA ProSeal | During intubation procedure | Insertion of the LMA ProSeal will be assessed on a 4-point scale (1, no resistance; 2, moderate resistance; 3, severe resistance; and 4, impossible to insert the LMA ProSeal). |
| Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site. | 1 minutes after intubation | It will be evaluated with a fibreoptic bronchoscope placed inside the tube section of the the LMA ProSeal. Accuracy will be recorded on a five-point scale (1, only the glottis is observed; 2, the posterior surface of the epiglottis and the glottis are observed; 3, the anterior part or tip of the epiglottis and \>50% of the glottis are observed; 4, the folded down epiglottis and \<50% of the glottis are observed; 5, the glottis is completely hidden by the folded down epiglottis) |
| Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion. | 2 minutes after intubation | Tidal volume and peak inspiratory pressure with or without manoeuvre will be recorded with the same ventilator settings determined for all patients. |
| Oropharyngeal leak pressure | 5 minutes after induction of general anesthesia | Oropharyngeal leak pressure will be assessed by closing the expiratory valve of the circle system to 40 cmH2o, with a fresh gas flow of 3 L/min and noting the airway pressure when equilibrium is reached or an audible air leak occurs. |
Countries
Turkey (Türkiye)
Outcome results
None listed