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Comparison of Gastric Volume in I-gel and ProSeal Laryngeal Mask Airways

ConditionsNausea and Vomiting, PostoperativeSore-throat
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorDiskapi Yildirim Beyazit Education and Research Hospital

About this trial

This study was planned to compare the gastric insufflation volume between i jel and ProSeal laryngeal mask airway (LMA) and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with an ASA (American Society of Anesthesiologists) physical status score of 1 to 3

undergoing urological surgeries performed with I-gel or ProSeal LMA

Disqualifiers

Difficult airway

Clinically significant upper respiratory tract infection

Pre-existing airway disease

Pre-existing airway disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • i jel LMA

    Other intervention

    Patients will be inserted i jel laryngeal mask under general anesthesia.

  • proseal LMA

    Other intervention

    Patients will be inserted proseal laryngeal mask under general anesthesia.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: i jel groupExperimental treatment 1 intervention
Group B: proseal groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measurement of oropharyngeal leak pressure (OLP)

One minute after successful LMA placement and fixation, oropharyngeal leak pressure (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.

Time frame
Five minutes after successful LMA placement

Secondary outcomes

1

Gastric volume

Before induction of anesthesia, gastric ultrasonography will be performed by an experienced anaesthesiologist using a 2-5 MHz curved-array probe. The gastric antrum will be visualised in the sagittal plane in the epigastric region, located between the left lobe of the liver anteriorly, the aorta or inferior vena cava inferiorly, and the pancreas posteriorly. The gastric cross-sectional area (CSA) will be calculated using the following formula, assuming the antrum is elliptical: CSA = (A × B × π) / 4, where A is the anteroposterior diameter and B is the craniocaudal diameter. The estimated gastric volume will be calculated using a previously validated model for non-pregnant adults: Estimated gastric volume (mL) = 27 + (14.6 × ACSA \[cm²\]) - (1.28 × Age \[years\]).

Time frame
1 minute before induction of anesthesia
2

Gastric volume

End of the operation,befeore LMA removal gastric ultrasonography will be performed by an experienced anaesthesiologist using a 2-5 MHz curved-array probe. The gastric antrum will be visualised in the sagittal plane in the epigastric region, located between the left lobe of the liver anteriorly, the aorta or inferior vena cava inferiorly, and the pancreas posteriorly. The gastric cross-sectional area (CSA) will be calculated using the following formula, assuming the antrum is elliptical: CSA = (A × B × π) / 4, where A is the anteroposterior diameter and B is the craniocaudal diameter. The estimated gastric volume will be calculated using a previously validated model for non-pregnant adults: Estimated gastric volume (mL) = 27 + (14.6 × ACSA \[cm²\]) - (1.28 × Age \[years\]).

Time frame
End of the operation, 5 minutes before LMA removal,
3

fiberoptic view grading

The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible.

Time frame
Five minutes after successful LMA placement
4

Complications during i jel and propseal LMA removal (emerge)

Complications during SP\_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 \< 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded.

Time frame
One minute after i jel and propseal LMA removal

Other outcomes

1

sore throat

The presence or absence of sore throat will be recorded at the firsth postoperative hour.

Time frame
popstoperative 1. hour
2

sore throat

The presence or absence of sore throat will be recorded at the firsth postoperative hour.

Time frame
popstoperative 24. hours
3

dysphonia

The presence or absence of dysphonia will be recorded at the firsth postoperative hour.

Time frame
popstoperative 1. hour
4

dysphonia

The presence or absence of dysphonia will be recorded at the 24th postoperative hour.

Time frame
24 hours postoperatively

Sponsors and contacts

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Diskapi Yildirim Beyazit Education and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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