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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cricoid pressure group | Sham Comparator | Cricoid pressure will be applied during LMA ProSeal insertion. |
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| Paratracheal pressure group | Experimental | Paratracheal pressure will be applied during LMA ProSeal insertion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cricoid pressure | Other | Cricoid pressure will be applied during LMA ProSeal insertion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of insertion | 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. | During intubation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Sensation of resistance during inserting of LMA ProSeal | 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). | During intubation procedure |
| Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammet Korkusuz, MD | Karamanoglu Mehmetbey University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Taining and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
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There are two groups;
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patients, care providers, investigator and outcome assessors will be blinded.
| Paratracheal pressure | Other | Pratracheal pressure will be applied during LMA ProSeal insertion. |
|
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) |
| 1 minutes after intubation |
| Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion. | Tidal volume and peak inspiratory pressure with or without manoeuvre will be recorded with the same ventilator settings determined for all patients. | 2 minutes after intubation |
| Oropharyngeal leak pressure | 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. | 5 minutes after induction of general anesthesia |