Aerosol and Droplet Dispersion During Gastrointestinal Motility Investigations

Not Applicable

Completed

• Conditions: Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations
• Interventions: Other: Fluorescein; Other: Particle measurement

• Registration Number: NCT04687488
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Health care workers (HCW) at the endoscopy unit are at constant occupational risk for many infectious diseases as they perform daily procedures that are believed to generate aerosol and droplets, which may harvest respiratory pathogens. These daily procedures include for example High Resolution Impedance Manometry (HRiM), 24h multichannel intraluminal impedance-pH monitoring (MII-pH) and endoscopic investigations. It is well-known that these procedures may induce cough, and can generate aerosol and droplets (1). Previous research showed that respiratory pathogens can remain dispersed in aerosol for up to 3 hours and droplets with a viral load remain stable on plastic and stainless steel surfaces (2). Furthermore, it is known that high viral loads may be present in the nasal cavity, nasopharynx and the oropharynx (3). The impact of the occupational risk for HCW at the endoscopy unit was confirmed during the peak of the severe acute respiratory syndrome -coronavirus (SARS-CoV) outbreak, as confirmed in an online survey from 39 motility centers in Europe. This survey showed that 35 out of 39 centers reduced their capacity during the SARS-CoV outbreak in the month of March 2020 with a median of 100% (range 50-100%) for esophageal HRiM and with a median of 100% (range 80-100%) for MII-pH (4).

Therefore, with resumption of clinical activities during the recovery phase of the SARS-CoV outbreak, a number of guidelines and measures are taken to protect patients and personnel from viral spread. Patients are screened for SARS-CoV infection by reverse transcription polymerase chain reaction ((RT-)PCR) testing on a nasopharyngeal swab specimen prior to invasive investigations and they are required to wear a chirurgical facemask in the hospital at all times. Staff of the endoscopy and function testing units are wearing a chirurgical facemask, standard gloves, goggles, hairnet and a water-resistant gown. Moreover, patients are required to keep a surgical mask over their mouth during the naso-gastric probe positioning, and the bed is lowered so that the head of the patient is below the neck level of the technician. Throughout the procedure, the technician positions him- or herself to the side and back of the patient. However, there is a lack of scientific evidence on the amount of aerosol and droplet spread when these procedures are being performed, with the safety measures that are outlined (1, 4).

Study Timeline

• Study Start: 2020-07-23
• Primary Completion: 2020-11-09
• Study Completion: 2020-11-09
• Status Verified: 2020-12
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescein	Fluorescein	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.
Fluorescein	Particle measurement	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.

Primary Outcome Measures

Name	Time	Method
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.	After the motility investigation (within 1 hour)	Visualization of the number of droplets using a UV-lamp (wood lamp) to detect the spread of droplets.

Secondary Outcome Measures

Name	Time	Method
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).	Measurement of the aerosol particles in the room during motility investigations.

Trial Locations

Locations (1)

TARGID; 🇧🇪 Leuven, Vlaams-Brabant, Belgium