NCT03036774

Brief Summary

The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

3 active sites

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 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

February 14, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 27, 2017

Last Update Submit

January 13, 2020

Conditions

Diabetes

Keywords

Gastric contentsUltrasoundDiabetes

Outcome Measures

Primary Outcomes (1)

  • Number of patients with full stomach

    The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area \> 340 mm2 The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area \> 340 mm2

    one day

Secondary Outcomes (6)

  • Glycemia

    one day

  • Fast duration

    one day

  • Glycated hemoglobin

    one day

  • Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)

    one day

  • Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)

    one day

  • +1 more secondary outcomes

Study Arms (2)

Diabetic patient

EXPERIMENTAL

Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area

Procedure: Ultrasonic measurement of antral area

Non diabetic patient

OTHER

Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease. Ultrasonic measurement of antral area

Procedure: Ultrasonic measurement of antral area

Interventions

Ultrasonic measurement of antral areaPROCEDURE

Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent. Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4. Antral area will correspond to the average of the three measures.

Diabetic patientNon diabetic patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged over 18
  • American Society of Anesthesiologists (ASA) classification 1 to 3
  • Needed a general anesthesia for a programmed surgical intervention
  • Respect of instructions of the pre-operative fasting;
  • Affiliation to the social security;
  • Consent form signed
  • Pregnant or breastfeeding women
  • Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum)
  • Patients treated with a prokinetic treatment and / or a level 3 analgesic

You may not qualify if:

  • Unfeasibility to ultrasound measurement of antral area
  • Failure to observe fasting instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fondation Ophtalmologique Adolphe de Rotschild

Paris, 75019, France

Location

AP-HP Hopital Tenon

Paris, 75020, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julien Rousset, MD

    Hôpital Tenon

    PRINCIPAL INVESTIGATOR

  • Marc Fischler, MD-PhD

    Hôpital Foch

    STUDY CHAIR

  • Francis Bonnet, MD-PhD

    HopitalTenon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 30, 2017

Study Start

February 14, 2017

Primary Completion

February 6, 2019

Study Completion

February 6, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)