Feasibility Study of a Non-invasive Device to Quickly, Easily and Accurately Measure Respiration in a Clinical Setting

NCT04182711 | Unknown

• 1 other identifier: 1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare facilities worldwide still measure respiration manually by counting and timing chest movements. In clinical departments that are fast-paced in nature and that have either high patient volumes or require more accurate measurements (e.g. emergency and respiratory wards), manual methods of counting respiration can be slow, laborious and highly subjective. While potential solutions such as electrocardiography (ECG) and capnography (CPG) have been explored for more objective monitoring of respiration, they are not fast enough due to long setup times to get patient and system ready and prolonged periods of connection to patients. Furthermore, such ECG/CPG based solutions can be costly, are generally sufficient for patients in high dependency units, and may be impractical to deploy in a remote setting.

Conditions

COPD

Keywords

COPD; Asthma; Pneumonia; Congestive heart failure

Outcome Measures

Primary Outcomes (1)

• Accuracy of this device on disease subjects in a clinical setting.

  The device will be compared against "gold-standard" manual counting and against existing technologies such as lead-based ECG, capnography and acoustic-based sensing.

  4.5 Months

Study Arms (1)

Device Arm

EXPERIMENTAL

The aim in the 1st phase is to benchmark the device against manual counting of respiration (number of breaths per minute). The aim in the 2nd phase is to benchmark the device against existing technologies, namely lead-based-ECG sensing, acoustic sensing and capnography. This phase can have a mix of patients having either COPD, asthma, pneumonia or any other respiratory diseases

Device: Device

Interventions

Device DEVICE

Phase 1: Time taken for each patient is 25 mins Phase 2: Time taken for each patient is 30 mins

Device Arm

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with cardio-respiratory diseases of either asthma, COPD, pneumonia, congestive heart failure or any other respiratory diseases.
• Patients should be able to provide informed consent either personally or through the next-of-kin. The study will consider a mix of mild to severe cases and will not be specific to either gender, sex or ethnicity.
• Patients with congestive heart failure only from general ward or cardiology high dependency units.

You may not qualify if:

• Patients that are either mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women.
• Patients with metallic/electrical implants e.g. pacemakers, cardiac devices, airway stents, neurostimulators etc.
• Patients with coronary stents insitu are eligible for enrolment into the study. Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment will further be excluded.
• Congestive heart failure patients on antibiotics or with infection.
• Congestive heart failure patients beyond 72 hours of presentation from enrolment. Intent is to capture congestive heart failure at the acute stage, prior to resolving.

Sponsors & Collaborators

• Changi General Hospital: lead
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

Clinical Trials & Research Unit

Singapore, 529889, Singapore

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Pneumonia; Heart Failure

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Dr Augustine Tee

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Yap

CONTACT

68502379; carolyn.yap.s.y@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: December 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)