HFNC and NIV for COVID-19 Complicated by Respiratory Failure

NCT04452708 | Completed DMC

• 1 other identifier: 2020.203
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Patients with COVID-19 have a range of clinical spectrum from asymptomatic infection, mild illness, moderate infection requiring supplemental oxygen and severe infection requiring intensive care support. High flow nasal cannula (HFNC) oxygen therapy and noninvasive ventilation (NIV) may offer respiratory support to patients with COVID-19 complicated by acute hypoxemic respiratory failure if conventional oxygen therapy (COT) fails to maintain satisfactory oxygenation but whether these respiratory therapies would lead to airborne viral transmission is unknown. Aims: This study examines whether SARS-2 virus can be detected in small particles in the hospital isolation rooms in patients who receive a) HFNC, b) NIV via oronasal masks and c) conventional nasal cannula for respiratory failure. Method: A field test to be performed at the Prince of Wales hospital ward 12C single bed isolation room with 12 air changes/hr on patients (n=5 for each category of respiratory therapy) with confirmed COVID-19 who require treatment for respiratory failure with a) HFNC up to 60L/min, b) NIV via oronasal masks and c) conventional nasal cannula up to 5L/min of oxygen. While the patient is on respiratory support, we would position 3 stationary devices in the isolation room (one next to each side of the bed and another at the end of the bed) of the patient with confirmed COVID-19 infection, and sample the air for four hours continuously. Results \& implications: If air sampling RTPCR and viral culture is positive, this would objectively confirm that HFNC and NIV require airborne precaution by healthcare workers during application.

Conditions

Respiratory Failure

Keywords

HFNC; NIV; oxygen; COVID-19

Outcome Measures

Primary Outcomes (1)

• detection of viral RNA from one or more participants' air samples

  quantitative RTPCR from air samples

  within 4 hours after starting respiratory therapy

Secondary Outcomes (1)

• the nasopharyngeal flocked swab and throat swab viral load (log10 copies/mL)

  up to 2 weeks

Study Arms (3)

HFNC at 30-60L/min

HFNC at 50-60L/min with humidification at 37C (Airvo 2, Fisher \& Paykel, Auckland, New Zealand) will be applied for patients with moderate type 1 respiratory failure

Device: HFNC

NIV

NIV (Respironics V60) via oronasal mask (Quattro, ResMed) will be reserved for patients with type 2 respiratory failure

Conventional nasal oxygen

Oxygen 1-5 L/min via nasal cannula for those with mild type 1 respiratory failure

Interventions

HFNC DEVICE

HFNV vs NIV vs conventional nasal cannula

Also known as: NIV, Conventional nasal cannula

HFNC at 30-60L/min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a field test being conducted at the Prince of Wales hospital ward 12C single bed isolation room with 12 air changes per hr on patients (n=5 for each category of respiratory therapy) with confirmed COVID-19 who require treatment for respiratory failure with a) HFNC up to 60L/min, b) NIV via oronasal masks and c) conventional nasal cannula up to 5L/min of oxygen. Five patients in each treatment category will be recruited as the majority (80%) of confirmed cases in HK have been mild without respiratory failure.

You may not qualify if:

• inability to provide consent;
• severe respiratory failure requiring invasive ventilatory support;
• septic shock

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NIOSH air samplers are located around the sampling bed ('Centre'), on the side of the sampling bed ('Side'), or relocated during the period of the sampling and application of each respiratory therapy. Air is collected at 3.5L/minute into three size fractions: \>4μm (collected in a 15ml tube), 1-4μm (1.5ml tube) and \<1μm (by a polytetrafluoroethylene (PTFE) membrane filter with 3.0μm pore size). All the tubes are then transported to the laboratory at 4°C, vortexed, and the VTM is aliquoted and stored at -80°C for subsequent laboratory analysis by RT-PCR. Viral loads will be measured from the patient's upper respiratory tract (nasopharyngeal flocked swab and throat swab) on admission and serially second daily during hospitalization by means of quantitative RT-PCR assay.

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• David S Hui, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: June 30, 2020
• Study Start: June 11, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

HK (1)