Bleeding Clinical Trial
Official title:
Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery: a Prospective Cohort Study
Verified date | September 2023 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adenoidectomy and/or tonsillectomy are performed for many reasons such as recurrent tonsil and adenoid infections, sleep apnea, symptomatic adenotonsillar hypertrophy, halitosis, peritonsillar abscess, and it is one of the most performed surgeries in the world. Passive blood loss from the surgical field into the gastric area may occur during the surgery. Investigators wonder whether the amount of blood and fluid accumulated in the stomach after tonsillectomy and/or adenoidectomy in children will increase the risk of aspiration. For this purpose, the aim is to compare the results with values considered risky for aspiration by evaluating the pre- and postoperative gastric volume with ultrasound in children who underwent elective adenoidectomy and /or tonsillectomy.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: - Undergoing elective adenotonsillectomy surgery overnight fasting - 1-18 years of age - Accepting to the join the study - American Society of Anesthesiology (ASA) classification I-II-III Exclusion Criteria: - Age older than 18 years - Preoperative vomiting or antiemetic medication therapy - Intubation more than needing more than two laryngoscopy attempts - Not given approval from the parents - Disease or conditions affecting gastric volume or motility |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University, Department of Anesthesiology | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
Bisinotto FM, Pansani PL, Silveira LA, Naves AA, Peixoto AC, Lima HM, Martins LB. Qualitative and quantitative ultrasound assessment of gastric content. Rev Assoc Med Bras (1992). 2017 Feb;63(2):134-141. doi: 10.1590/1806-9282.63.02.134. — View Citation
Desgranges FP, Gagey Riegel AC, Aubergy C, de Queiroz Siqueira M, Chassard D, Bouvet L. Ultrasound assessment of gastric contents in children undergoing elective ear, nose and throat surgery: a prospective cohort study. Anaesthesia. 2017 Nov;72(11):1351-1356. doi: 10.1111/anae.14010. Epub 2017 Aug 14. — View Citation
Zhang G, Huang X, Shui Y, Luo C, Zhang L. Ultrasound to guide the individual medical decision by evaluating the gastric contents and risk of aspiration: A literature review. Asian J Surg. 2020 Dec;43(12):1142-1148. doi: 10.1016/j.asjsur.2020.02.008. Epub 2020 Mar 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastric volume (ml/kg) | Gastric volumes are going to be calculated | During the operation | |
Secondary | The cross sectional area (ACSA) (preoperative)(mm2) | measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4 | preoperative | |
Secondary | The cross sectional area (ACSA) (after intubation)(mm2) | measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4 | immediately after intubation | |
Secondary | The cross sectional area (ACSA) (postoperative)(mm2) | measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4 | 10 minutes before extubation | |
Secondary | postoperative presence and severity of PONV | The severity of PONV was assessed according to the four points score :
None (0 point) nausea (1 point) , nausea with maximum of two vomiting episodes (2 points) , more than two vomiting episodes (3 points) |
at the first, second and 24th hours in PACU and at the ward. | |
Secondary | blood volume in suction system | weighing sponge, pad, and blood volume in the aspirator | intraoperative | |
Secondary | duration of surgery | the time from the start of the surgery to the end of the surgery | Intraoperative (throughout the surgical procedure) |
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