Remotely guided self-performed lung ultrasound for COVID
| ISRCTN | ISRCTN14491490 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14491490 |
| Secondary identifying numbers | 01 |
- Submission date
- 05/09/2022
- Registration date
- 10/09/2022
- Last edited
- 09/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 pneumonia is disrupting life on the planet earth in an unprecedented fashion. While many if not most people have mild or asymptomatic disease, others, even young previously healthy people, may become rapidly sick with severe hypoxia despite exhibiting minimal symptoms, including shortness of breath (dyspnea). The burden on health care systems may be extraordinary, with even well-developed nations’ health care systems being overwhelmed. Health care providers may be particularly susceptible if appropriate infection prevention and control measures are not in place. Thus, solutions need to be sought to provide excellent patient care, but also to protect provider health. COVID-19 is a paradox, as, despite the risk to providers, the majority contracting the virus will not develop COVID-19 pneumonia. Most will have none or minor symptoms and can safely self-isolate at home. However, those who develop severe disease, need to be identified early. Compared to chest x-rays (radiography) and the imaging procedure computed tomography (CT), lung ultrasound (LUS; a procedure that uses high-frequency sound waves to create an image) is a simpler, more portable, economical, and potentially home-based technology that might be used for at-risk patients to self-monitor their lungs for early signs of COVID-19 pneumonia. Findings from COVID-19 pneumonia are typically present in the lung periphery, an anatomic fact that permits LUS to be used to diagnose and manage all phases of care in COVID-19. LUS may detect early disease progression as the lungs worsen from normal to diseased. Through work onboard the International Space Station examining telementored lung ultrasonography (SPTMLUS) self-performed by inexperienced point-of-care users guided by remote experts, we have long known that accurate ultrasound images of the lungs can be self-obtained. What has never been examined, is whether willing but ultrasound-naïve adults can be remotely mentored to obtain meaningful lung ultrasound images upon themselves for lung diseases, such as COVID-19. The purpose of this study was to examine the feasibility and quality of SPTMLUS for novices when expertly guided. Furthermore, this paradigm may be considered a specific example of a broader concept that may contribute to many facets of patient-focused and individualized healthcare.
Who can participate?
Adults self-isolating due to COVID-19 infection
What does the study involve?
A lung ultrasound expert will guide the participants using teleconferencing software to measure their own blood pressure and conduct a standardized lung examination.
What are the possible benefits and risks of participating?
The potential benefits of the study were learning new knowledge including a better understanding of the volunteers' own physiology. The most pertinent risk of participating in anything during strict isolation protocols is being exposed to the agent people were isolated from; in this case the COVID virus. Thus, the ultrasound probe, cell phone, blood pressure cuff, and pulse oximeter were repeatedly sanitized and wrapped in sterile packing and there was no human-to-human contact at any point in the study.
Where is the study run from?
Foothills Medical Centre (Canada)
When is the study starting and how long is it expected to run for?
January 2020 to October 2020
Who is funding the study?
The University of Calgary, The Office of Surgical Research, Department of Surgery (Canada)
Who is the main contact?
Prof Andrew Kirkpatrick (Canada)
andrew.kirkpatrick@albertahealthservices.ca
Contact information
Principal Investigator
Trauma Services
EG23
Foothills Medical Centre
1403 29 St NW
Calgary, Alberta
T2N 2T9
Canada
| Phone | +1 (0) 403 870 7998 |
|---|---|
| andrew.kirkpatrick@albertahealthservices.ca |
Study information
| Study design | Single-centre uncontrolled interventional unmasked study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Screening |
| Participant information sheet | 42329 V12_IN_1 Informed Consent for Telementored Self-performed lung ultrasound.PDF |
| Scientific title | Empowering the willing: The feasibility of tele-mentored self-performed pleural ultrasound assessment for the surveillance of lung health |
| Study objectives | Can ultrasound-naive members of the lay public be remotely guided to obtain interpretable and accurate ultrasound images of their own lungs |
| Ethics approval(s) | Approved 16/04/2020, Certification of Institutional Ethics Approval, The Conjoint Health Research Ethics Board (CHREB), (University of Calgary, Research Services Office, 2500 University Drive NW, Calgary AB T2N 1N4, Canada; +1 (403) 220-2297; resethic@ucalgary.ca), ref: REB14-0634_MOD4 |
| Health condition(s) or problem(s) studied | Early COVID 19 pneumonia |
| Intervention | After informed consent, participants will complete an electronic demographic survey and receive a package containing a disinfected hand-held high-frequency linear ultrasound probe (Philips Lumify, Philips, Amsterdam, NL), and a package of sterile ultrasound gel. Participants will be directed to watch a brief instructional video on how to hold the probe and where anatomically they would be guided to scan. A lung ultrasound expert will then remotely mentor and guide participants to measure their blood pressure and conduct a standardized lung examination with the hand-held ultrasound device based on the 14-zone method proposed by Soldati for International Standardization of the Use of Lung Ultrasound for Patients with COVID-19. Images will be optimized through remote control of ultrasound “knobology” by the mentor using remote access software (Teamviwer). The pleural interface will be interrogated with 2D, M-mode, and color-Power Doppler (CPD) modes, and all image acquisition attempts will be video recorded. The results will be scored in real-time by the mentor using the proposed Soldati method from 0 (normal) to 3 (very abnormal) and the number of B-lines present at each anatomic location will be counted. Each participant will be asked to complete an online post-test evaluation that includes their perceptions of the difficulty in performing their self-examination including a 5-point Likert scale rating the examination at each location as being one of; 1—Very Hard, 2—Hard, 3—Neutral, 4—Easy, 5—Very Easy. An a-priori planned independent review will be undertaken by three outside lung ultrasound experts, who will rate both the image quality (as adequate versus inadequate) and the degree of abnormality using the same Soldati scoring protocol. |
| Intervention type | Other |
| Primary outcome measure | Acquisition of good-quality interpretable images based on the 14-zone method proposed by Soldati for International Standardization of the Use of Lung Ultrasound for Patients with COVID-19 as assessed by the lung ultrasound expert during telementored self-performed lung ultrasound |
| Secondary outcome measures | 1. The ability for volunteers to physically reach each anatomic location of a standard recommended COVID lung ultrasound examination as assessed by the lung ultrasound expert during telementored self-performed lung ultrasound 2. Calculated test performance characteristics of standard lung examination protocols recommending a variety of differing anatomic assessment locations measured using the Likert scale generated by the lung ultrasound experts reviewing the telementored self-performed lung ultrasound, and patient self-rated user difficulty scores of a different Likert scale following the examination |
| Overall study start date | 04/01/2020 |
| Completion date | 20/10/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 27 |
| Key inclusion criteria | Adults self-isolating according to public health measures for the purpose of reducing person to person transmission of COVID 19 |
| Key exclusion criteria | 1. Non-English speaking 2. Illiterate 3. Not willing to participate |
| Date of first enrolment | 01/05/2020 |
| Date of final enrolment | 20/10/2020 |
Locations
Countries of recruitment
- Canada
Study participating centre
Calgary
T2N 2T9
Canada
Sponsor information
University/education
Department of Surgery
Calgary
T2N 2T9
Canada
| Phone | +1 403 210 9300 |
|---|---|
| oberle@ucalgary.ca | |
| Website | https://www.ucalgary.ca/ |
"ROR" |
https://ror.org/03yjb2x39 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- UCalgary, University of Calgary in Alberta, The University of Calgary, Normal School, Calgary Normal School, Calgary Branch of the Faculty of Education of the University of Alberta, University of Alberta in Calgary, U of C
- Location
- Canada
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | De-identified participant-level data may be obtained from the Investigators if permitted by Ethical Concerns |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/01/2022 | 06/09/2022 | Yes | No | |
| Participant information sheet | version 12 | 16/04/2020 | 09/09/2022 | No | Yes |
Additional files
Editorial Notes
09/09/2022: The trial's existence was confirmed by the Conjoint Health Research Ethics Board (CHREB), University of Calgary.
