NCT05734937

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

January 20, 2023

Last Update Submit

September 30, 2023

Conditions

Gastric VolumeAspirationNauseaBleeding

Outcome Measures

Primary Outcomes (1)

  • Gastric volume (ml/kg)

    Gastric volumes are going to be calculated

    During the operation

Secondary Outcomes (6)

  • The cross sectional area (ACSA) (preoperative)(mm2)

    preoperative

  • The cross sectional area (ACSA) (after intubation)(mm2)

    immediately after intubation

  • The cross sectional area (ACSA) (postoperative)(mm2)

    10 minutes before extubation

  • postoperative presence and severity of PONV

    at the first, second and 24th hours in PACU and at the ward.

  • blood volume in suction system

    intraoperative

  • +1 more secondary outcomes

Study Arms (1)

gastric assessment of gastric volume

EXPERIMENTAL

ultrasound assessment of gastric volume in Preoperative and postoperative period in right lateral decubitus position in pediatric patients

Other: gastric assessment of gastric volume

Interventions

gastric assessment of gastric volumeOTHER

ultrasound assessment of gastric volume is going to bel evaluted in the Preoperative and postoperative period while the patients lay in right lateral decubitus position.

gastric assessment of gastric volume

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Undergoing elective adenotonsillectomy surgery overnight fasting
  • years of age
  • Accepting to the join the study
  • American Society of Anesthesiology (ASA) classification I-II-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28805238BACKGROUND

  • 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.

    PMID: 32171605BACKGROUND

  • 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.

    PMID: 28355374BACKGROUND

MeSH Terms

Conditions

NauseaHemorrhage

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Hilal Öztürk, Resident

    Istanbul University

    PRINCIPAL INVESTIGATOR

  • Demet Altun, Assoc. Prof

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 21, 2023

Study Start

May 10, 2023

Primary Completion

September 20, 2023

Study Completion

September 30, 2023

Last Updated

October 3, 2023

Record last verified: 2023-09

Locations

TU(1)