Aerosol and Droplet Dispersion During Gastrointestinal Motility Investigations

NCT04687488 | Completed

• 1 other identifier: S64237
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To obtain more knowledge about the generation of aerosol and droplet dispersion and deposition during naso-gastric intubation for gastrointestinal motility investigations

Conditions

Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations

Outcome Measures

Primary Outcomes (1)

• Number of droplets spread on the investigator and their location on gown or goggles, by the end of the procedure of naso-gastric intubation for gastrointestinal motility investigations.

  Visualization of the number of droplets using a UV-lamp (wood lamp) to detect the spread of droplets.

  After the motility investigation (within 1 hour)

Secondary Outcomes (1)

• Generation of aerosol particles by insertion and by removal of the naso-gastric motility or pH monitoring probe.

  Before placement of the probe (1 and 5 minutes) and after the removement of the probe (1 and 5 minutes).

Study Arms (1)

Fluorescein

OTHER

Fluorescein dye and ultraviolet (UV) light are used to assess the aerosol contamination during endonasal investigations. We will dilute medical fluorescein vials (FLUORESCEINE 10% Faure; SERB, 40 Avenue George V, 75008 Paris, France) to a concentration of 1% fluorescein in 10ml of normal saline solution. Next, we swab the nasal cavity with a compress soaked (15 droplets with a pipette) in fluorescein and we apply 5 droplets into the nasal cavity and nasopharynx at the beginning of the investigation. After coating the nose with fluorescein, the patient will wear a surgical nose-mouth mask and will be positioned in the bed used for HRiM or MII-pH probe insertion. As the MII-pH probe is removed 24h after placement of the probe, prior to this activity the same fluorescein application method (fluorescein drops and a cotton swab) will be used.

Other: Fluorescein; Other: Particle measurement

Interventions

Fluorescein OTHER

For droplet visualization, we will use fluorescein, which has been used for many years in medicine for diagnostic purposes and is safe upon topical administration, as a tracer. There are no local or systemic side effects of topical sodium fluorescein (5). Fluorescein is routinely used in the mouth to stain dental plaque (6). Through the lacrimal duct, the nasal cavity is exposed to fluorescein when it is used for ophthalmological purposes (7). Allergic reactions have been described to intravenous injection, which is not part of our trial. In the setting of head-and-neck and otolaryngological surgeries, coating the mouth with fluorescein has been used to quantify droplet spread, to assess for risk of transmission of COVID-19 (8). Hence, fluorescein can be safely applied to nasal and oropharyngeal cavities. We will use a similar approach, coating the nasal cavity, to study droplet spread from the nose during naso-gastric intubation for motility or reflux testing.

Fluorescein

Particle measurement OTHER

Quantification of aerosol will be done using a medical particle counter, as used for hospital safety measurements.

Fluorescein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>18 years old;
• Male or female patients;
• Patients undergoing elective gastrointestinal motility investigations (MII-pH and HRiM);
• Negative PCR on nasopharyngeal swab 24 hours prior to the test;
• No anatomical deformity of nose and throat, no known diseases of nose and throat;
• Signed informed consent.

You may not qualify if:

• Females who are pregnant or lactating;
• Use of anticoagulant medication;
• Known allergy to fluorescein.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

TARGID

Leuven, Vlaams-Brabant, Belgium

Location

MeSH Terms

Interventions

Fluorescein

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

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: Prof. Dr.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 29, 2020
• Study Start: July 23, 2020
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

BE (1)