Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility InvestigationsNCT04687488
Aerosol and Droplet Dispersion During Gastrointestinal Motility Investigations
A study testing Fluorescein and Particle measurement in people with Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To obtain more knowledge about the generation of aerosol and droplet dispersion and deposition during naso-gastric intubation for gastrointestinal motility investigations Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations
- What is being tested?
- Fluorescein and Particle measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jul 2020to 9 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Females who are pregnant or lactating;
- Use of anticoagulant medication;
- Known allergy to fluorescein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19: The Study of Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations
To obtain more knowledge about the generation of aerosol and droplet dispersion and deposition during naso-gastric intubation for gastrointestinal motility investigations
Read the 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).
- Being tested
- Fluorescein, Particle measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinOther
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.
Particle measurementOther
Quantification of aerosol will be done using a medical particle counter, as used for hospital safety measurements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fluorescein; Other: Particle measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measurement of the aerosol particles in the room during motility investigations.
Measured: Before placement of the probe (1 and 5 minutes) and after the removement of the probe (1 and 5 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start23 Jul 2020
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility InvestigationsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687488
- Sponsor's protocol ID
- S64237
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: The Study of Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations
- ClinicalTrials.gov ID
- NCT04687488
- Acronym / sponsor ID
- S64237
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescein | Other | Other: Fluorescein, Other: Particle measurementFluorescein 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Females who are pregnant or lactating;
- Use of anticoagulant medication;
- Known allergy to fluorescein.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoresceinFor 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. | Other | Fluorescein |
| Particle measurementQuantification of aerosol will be done using a medical particle counter, as used for hospital safety measurements. | Other | Fluorescein |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
Generation of aerosol particles by insertion and by removal of the naso-gastric motility or pH monitoring probe.
Time frame: Before placement of the probe (1 and 5 minutes) and after the removement of the probe (1 and 5 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescein and Particle measurement in people with Aerosol Generation and Droplet Dispersion and Deposition During Naso-gastric Intubation for Gastrointestinal Motility Investigations, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: After the motility investigation (within 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.