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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.
Supraglottic airway devices (SADs) are widely used in both elective and emergency surgeries, resuscitation, and difficult airway management. Compared to endotracheal intubation, they are less invasive, require lower doses of anaesthetic agents, and cause less haemodynamic instability. Among supraglottic airway devices, the I-gel differs from other SADs in that it does not have an inflatable cuff; instead, it features a soft structure made of a transparent thermoplastic elastomer that mimics a cuff. In addition, it has a gastric channel alongside the airway tube that allows for gastric aspiration.
ProSeal LMA is one of the most commonly used SADs in clinical practice. It was developed in the early 2000s as a modification of the classic LMA and includes an inflatable cuff. Like the I-gel, it also features a gastric drainage channel for aspiration.
Aspiration pneumonia is a serious complication of anaesthesia, accounting for approximately 9% of all anaesthesia-related mortality. Traditionally, oropharyngeal leak pressure (OLP) provides information about the potential for gastric insufflation and thus the risk of gastric aspiration. Measurement of the gastric antral cross-sectional area (AGCA) by ultrasound allows for the estimation of gastric volume and helps assess the risk of aspiration.
This study was planned to compare the gastric insufflation volume between i jel and ProSeal LMA and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i jel group | Experimental | under general anesthesia, patients inserted i jel LMA |
|
| proseal group | Experimental | under general anesthesia, patients inserted proseal LMA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i jel LMA | Other | Patients will be inserted i jel laryngeal mask under general anesthesia. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Five minutes after successful LMA placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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]). |
| Measure | Description | Time Frame |
|---|---|---|
| sore throat | The presence or absence of sore throat will be recorded at the firsth postoperative hour. | popstoperative 1. hour |
| sore throat | The presence or absence of sore throat will be recorded at the firsth postoperative hour. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeynep Koç | Contact | 05345958843 | zeynepyilmazkoc@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Koç | Yenimahalle | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36110490 | Background | Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug. | |
| 36630297 |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| proseal LMA |
| Other |
Patients will be inserted proseal laryngeal mask under general anesthesia. |
|
| 1 minute before induction of anesthesia |
| 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]). | End of the operation, 5 minutes before LMA removal, |
| 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. | Five minutes after successful LMA placement |
| 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. | One minute after i jel and propseal LMA removal |
| popstoperative 24. hours |
| dysphonia | The presence or absence of dysphonia will be recorded at the firsth postoperative hour. | popstoperative 1. hour |
| dysphonia | The presence or absence of dysphonia will be recorded at the 24th postoperative hour. | 24 hours postoperatively |
| Zhou S, Cao X, Zhou Y, Xu Z, Liu Z. Ultrasound Assessment of Gastric Volume in Parturients After High-Flow Nasal Oxygen Therapy. Anesth Analg. 2023 Jul 1;137(1):176-181. doi: 10.1213/ANE.0000000000006340. Epub 2023 Jan 11. |
| 32493213 | Result | Ye Q, Wu D, Fang W, Wong GTC, Lu Y. Comparison of gastric insufflation using LMA-supreme and I-gel versus tracheal intubation in laparoscopic gynecological surgery by ultrasound: a randomized observational trial. BMC Anesthesiol. 2020 Jun 3;20(1):136. doi: 10.1186/s12871-020-01057-z. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |