Karaman Taining and Research Hospital
Karaman, 70200, Turkey (Türkiye)
NCT Number: NCT06616740
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Karaman, 70200, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cricoid pressure will be applied during LMA ProSeal insertion.
Pratracheal pressure will be applied during LMA ProSeal insertion.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Karaman Training and Research Hospital
Other
Comparison of the Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement: a Randomised Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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