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The goal of this clinical trial is to to evaluate the sealing quality of three second-generation SADs (ProSeal LMA, i-gel, and i-gel Plus) using ultrasonography to measure the cross-sectional area (CSA) of sealing, Anterior-Posterior (AP) Diameter and Transverse (TV) Diameter ,percentage of effective sealing , presence of sealing gap and correlate these anatomical findings with oropharyngeal leak pressure (OLP), while simultaneously testing relevant safety features of regurgitation risk through salivary pH measurement.
The findings from this investigation may contribute to improved device selection and enhanced patient safety during procedures requiring supraglottic airway management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group P: ProSeal. | Active Comparator | Using computer-generated random numbers to assign patients to one of the three device groups: First group is Group P: ProSeal |
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| Group I: i-gel. | Active Comparator | Using computer-generated random numbers to assign patients to one of the three device groups: Second group Group I: i-gel. |
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| Group I+: i-gel Plus. | Active Comparator | Using computer-generated random numbers to assign patients to one of the three device groups: Third group Group I+: i-gel Plus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitation | Other | This multimodal approach, combining ultrasound assessment of sealing quality with biochemical monitoring of regurgitation, may provide valuable insights into the comparative effectiveness of different SAD designs and ensure patient safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound mapping of sealing efficacy with correlation to OLP | evaluate the sealing quality of three second-generation SADs (ProSeal LMA, i-gel, and i-gel Plus) using ultrasonography to measure the cross-sectional area (CSA) of sealing, Anterior-Posterior (AP) Diameter and Transverse (TV) Diameter ,percentage of effective sealing , presence of sealing gap and correlate these anatomical findings with oropharyngeal leak pressure (OLP). | The primary outcome will be assessed throw the operation time from 2 hours to 4 hours time frame to obtain this outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment for Regurgitation and microaspiration | Post insertion of device, place a Salivary Collection Device in the oropharynx via the drainage channel for 5 minutes to collect secretion. Post-operatively A sample of saliva will be collected by the anesthesiologist, and the sample PH will be checked. | Throw operative time a base line and at the end of operation before emergence of anathesia. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine ain shams university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ahn, J. H., Jeong, J. S., Kang, S. H., Yeon, J. E., Cho, E. A., Choi, G. S., ... & Kim, G. S. (2021). Comparison of intragastric pressure between endotracheal tube and supraglottic airway devices in laparoscopic hepatectomy: A randomized, controlled, non-inferiority study. Medicine, 100(24), e26287. Jung, Y., Jung, S., Yu, S., Jeong, M. A., & Kim, C. L. (2024). Gastric distension and atelectasis after using a supraglottic airway-A case report. Anesthesia and Pain Medicine, 19(3), 261-265. O'Riordan, C., Van De Ven, P., Nelson, J., McCreesh, K., & Clifford, A. (2016). Reliability of a measurement method for the cross-sectional area of the longus colli using real-time ultrasound imaging. Ultrasound, 24(3), 154-162. Solanki, S. L., Johnson, J. E., & Samantaray, A. (2020). Supraglottic airway devices: Placement and pharyngeal seal matters!. Indian Journal of Anaesthesia, 64(8), 649-652. Werner, J., Klementova, O., Bruthans, J., Macoun, J., Gaszynski, T., Henlin, T., ... & Michalek, P. (2024). Evaluation of the i-gel® Plus supraglottic airway device in elective surgery: a prospective international multicentre study. Anaesthesia, 79(12), 1284-1291. Zhang, K., Zhou, M., Zou, Z., Zhu, C., & Jiang, R. (2024). Supraglottic airway devices: a powerful strategy in airway management. American journal of cancer research, 14(1), 16., ISO 690. |
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| evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitation | Other | This multimodal approach, combining ultrasound assessment of sealing quality with biochemical monitoring of regurgitation, may provide valuable insights into the comparative effectiveness of different SAD designs and ensure patient safety. |
|
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| evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation | Other | This multimodal approach, combining ultrasound assessment of sealing quality with biochemical monitoring of regurgitation, may provide valuable insights into the comparative effectiveness of different SAD designs and ensure patient safety. |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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