Impact on gastric emptying measured by antral gastric ultrasound of erythromycin administration in stroke patients with indication for mechanical thrombectomy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Foch

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

completed 23 Feb 2024

Decision date (initial)

2024-02-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of erythromycin IVSE on decreasing antral surface area by emergency mechanical thrombectomy procedure in patients with ischemic stroke.

Secondary objectives 8

1. Estimate the percentage of full stomach (antral surface > 340 mm²) and empty stomach (antral surface < 340 mm²) situations on arrival in the interventional neuroradiology unit.
2. Estimate the proportion of patients with a 30% reduction in antral surface area after revascularization.
3. Compare the proportion of patients whose erythromycin administration was accompanied by effective gastric emptying (antral surface< 340 mm2 at the end of the procedure) with the proportion of post-procedure empty stomachs in the control group.
4. Describe the influence of antral ultrasound on anesthesia protocol
5. Determine the impact of strict flat-back or 45° proclivity on antral surface measurement
6. Estimate gastric volume from antral surface measured in lateral decubitus position
7. Evaluate the impact of erythromycin on patient prognosis during revascularization procedures
8. Evaluate the impact of erythromycin on patient prognosis during hospital stay

Conditions and MedDRA coding

Patient presenting to the neuroradiological emergency room with an ischemic stroke and requiring interventional neuroradiology for stroke. Only patients with significant gastric contents on ultrasound (stomach is full: antral area >340mm²) according to a measurement taken before the start of the procedure in the supine position will be randomized in the study.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Major patients with ischemic stroke
2. Requiring emergency interventional neuroradiology for mechanical thrombectomy for stroke, regardless of anesthetic procedure (AG or AL)
3. Informed consent obtained from the patient/relative or following an emergency procedure.
4. Being affiliated to a health insurance plan

Exclusion criteria 8

1. Pregnant woman
2. Deprived of liberty or under tutelage
3. Allergy to macrolides, curares (succinylcholine, rocuronium)
4. Nasogastric tube placement prior to interventional radiology admission
5. Patient already intubated on arrival
6. Minor or protected adult
7. Contraindication to erythromycin administration: known allergy, hepatic porphyria
8. Scheduled return trip, within less than 24 hours, to a neurology department outside Hôpital Foch

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the percentage reduction in antral surface area between the initial antral ultrasound and the antral ultrasound after the thrombectomy procedure in the neuroradiology unit.

Secondary endpoints 8

1. The frequency and proportion of patients randomized into the study after the first antral ultrasound for full stomach (with an ultrasonographic antral surface area > 340 mm2). The frequency and proportion of patients not randomized in the study (with an ultrasonographic antral surface < 340 mm2).
2. The proportion of patients with a 30% reduction in antral surface area between the measurement taken at the start of the procedure and that taken at the end of the procedure.
3. The frequency and proportion of patients with an ultrasound anal surface area < 340 mm2 at the end of the procedure.
4. Frequency and proportion of patients for whom ultrasound information had an influence (particularly knowledge of a full stomach) on anesthetic management strategy, as reported by the investigator: change in anesthetic strategy (Yes/No), decision to use orotracheal intubation (Yes/No), decision to place a nasogastric tube (Yes/No).
5. In patients who can benefit from an elevated head position after revascularization, digital measurements of the antral area and determination of the PERLAS score in strict dorsal recumbency followed by 45° proclivity.
6. Calculation of gastric volume in mm3 from antral surface measured in lateral decubitus position
7. The frequency and proportion of complications typically encountered during thrombectomy procedures: hypotension, desaturation, need to increase oxygen flow, difficult upper airway management, inhalation syndrome.
8. During the hospital stay: use of oxygen therapy at H+4 (Yes/No), possible post-procedure transfer to intensive care (Yes/No), occurrence of serious and non-serious adverse events related to erythromycin administration (Yes/No).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Foch

Sponsor organisation

Hospital Foch

Address

40 Rue Worth

City

Suresnes

Postcode

92150

Country

France

Scientific contact point

Organisation

Hospital Foch

Contact name

Sahar Sellami Jallouli

Public contact point

Organisation

Hospital Foch

Contact name

Elisabeth Hulier Ammar

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications