Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02983175
Other study ID # 2016-A01501-50
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 2, 2016
Last updated December 5, 2016
Start date December 2016
Est. completion date September 2017

Study information

Verified date December 2016
Source Central Hospital, Nancy, France
Contact Marie-Alix REGNIER-KIMMOUN, PH
Phone 03.83.85.14.03
Email ma.regnier@chru-nancy.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.

Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date September 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Patient admitted to the operating room for appendectomy.

- Major or minor patient (higher than 16) affiliated to a social security scheme.

- Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).

Exclusion Criteria:

- Pregnant women.

- Childbearing age patient does not have effective contraception.

- Breastfeeding woman.

- Minor patient under 16.

- Major patient subject to a measure of legal protection or unable to consent.

- Persons deprived of liberty by a judicial or an administrative decision.

- Patient with gastric and/or esophagus surgery history.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
ultrasound assessment of gastric content
Achievement of gastric ultrasound (specific procedure) : Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal. Standardised achievement of the antral ultrasound by the following method: First, a qualitative assessment of antral contents in 3 grades according to the "Perlas" method [24]. Second, performing a quantitative analysis of antral contents calculating the CSA. Then, volume of gastric contents calculation as from the CSA.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

References & Publications (3)

Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/AL — View Citation

Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250. — View Citation

Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015 Jan;122(1):39-45. doi: 10.1097/ALN.0000000000000512. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cross-section antral area (CSA) Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x p / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter baseline J0 Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05075252 - Re-assessment of Appendicitis Evaluation During Laparoscopic Appendectomy, Peritoneal Irrigation During Laparoscopic Appendectomy Does the Grade of Contamination Matter?
Completed NCT03349814 - Explanations for Negative Laparoscopic Appendectomies and Normal Laparoscopies
Completed NCT03510923 - Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy
Not yet recruiting NCT04294537 - TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: a Pilot Study N/A
Completed NCT03080103 - Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis
Completed NCT00371722 - Appendectomy Versus no Appendectomy With Cesarean Section N/A
Not yet recruiting NCT06395636 - Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients N/A
Completed NCT05099302 - The Effect of Cartoons Watched Before Surgery on Children's Fear Level N/A
Completed NCT04614519 - Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial N/A
Completed NCT06407622 - The Effect of Foot Reflexology on Patients Undergoing Appendectomy Surgery N/A
Completed NCT03947372 - Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis N/A
Not yet recruiting NCT06443749 - Closure of the Appendiceal Stump N/A
Recruiting NCT04464382 - Evaluating the Safety and Efficacy of a Outpatient Appendectomy N/A