AnesthesiaPatchNCT04344093
Validation of a Connected Patch, an Alternative to Conventional Monitoring
A study testing Patch validation in people with Anesthesia, run by CMC Ambroise Paré at 1 site in France.
Trial summary
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Patch validation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 29 Dec 2020to 3 Jun 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient over 18 and under 85 years of age
- patient requiring general anesthesia for extra-thoracic surgery
- the patient's position during the operation is in supine position only
- patient affiliated to or benefiting from social security, excluding State Medical Assistance
- patient with written consent
Who cannot join
- pregnant or breastfeeding patients
- patients known to have severe skin reactions to adhésives
- patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
- patients deprived of their liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.
Read the detailed description
When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.
The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.
One of the crucial issues is therefore the speed of the alarm and its reliability.
The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.
The connected patch used in this research is the Devinnova company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.
The objective of this research is therefore to validate Devinnova's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.
- Conditions
- Anesthesia
- Being tested
- Patch validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch validationDevice
Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature
| Study group | Role | What they receive |
|---|---|---|
| Connected patch validation | Experimental | Not described Receives: Device: Patch validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of blood pressure value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
Measured: 36 hours maximum after the surgery
Concordance of heart rate value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
Measured: 36 hours maximum after the surgery
Concordance of respiratory rate value measured by 2 different during the postoperative stay in the post-operative period in the post-anesthesia care unit
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
Measured: 36 hours maximum after the surgery
Concordance of arterial oxygen saturation value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
Measured: 36 hours maximum after the surgery
Concordance of temperature value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
Comparison between temperature measured by conventional medical monitoring device and by connected patch
Measured: 36 hours maximum after the surgery
Secondary outcomes (10)
Concordance of blood pressure value measured by 2 different devices during anesthesia
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
Measured: During anesthesia
Concordance of heart rate value measured by 2 different devices during anesthesia
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
Measured: During anesthesia
Concordance of respiratory rate value measured by 2 different devices during anesthesia
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
Measured: During anesthesia
Concordance of arterial oxygen saturation value measured by 2 different devices during anesthesia
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
Measured: During anesthesia
Concordance of temperature value measured by 2 different devices during anesthesia
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
Measured: During anesthesia
Blood pressure artifact
An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25%
Measured: From beginning of anesthesia to 36 hours
Heart rate artifact
An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25%
Measured: From beginning of anesthesia to 36 hours maximum after the surgery
Respiratory rate artifact
An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25%
Measured: From beginning of anesthesia to 36 hours maximum after the surgery
Arterial oxygen saturation artifact
An artifact is defined as any value that deviates from a physiologically plausible range or by a deviation > 50% from the previous value unless this value is followed by a value equal to ± 25%
Measured: From beginning of anesthesia to 36 hours maximum after the surgery
Acceptability of connected patch
The patient will be asked to evaluate its acceptance of the sensor using a 4-point Likert scale (from 0 = intolerable to 4 = no problem at all)
Measured: During the surgery and 36 hours maximum after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start29 Dec 2020
- Primary completion29 May 2022 (estimated)
- Study completion3 Jun 2022 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Connected patch validation
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc FISCHLER, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344093
- Sponsor's protocol ID
- 2019/11
- Acronym
- Patch
- Status last verified
- May 2021
- First submitted
- 9 Apr 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available in the Dryad repository
Publications
Le Guen M, Squara P, Ma S, Adjavon S, Trillat B, Merzoug M, Aegerter P, Fischler M. Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit. BMJ Open. 2020 Sep 25;10(9):e040453. doi: 10.1136/bmjopen-2020-040453.
PubMed 32978206
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Connected Patch, an Alternative to Conventional Monitoring
- ClinicalTrials.gov ID
- NCT04344093
- Acronym / sponsor ID
- Patch / 2019/11
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 29 May 2022 (estimated)
- Study completion
- 3 Jun 2022 (estimated)
- First posted
- 14 Apr 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.
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.
Detailed description
When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.
The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.
One of the crucial issues is therefore the speed of the alarm and its reliability.
The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.
The connected patch used in this research is the Devinnova company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.
The objective of this research is therefore to validate Devinnova's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Connected patch validation
| Arm | Type | Receives |
|---|---|---|
| Connected patch validation | Experimental | Device: Patch validation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient over 18 and under 85 years of age
- patient requiring general anesthesia for extra-thoracic surgery
- the patient's position during the operation is in supine position only
- patient affiliated to or benefiting from social security, excluding State Medical Assistance
- patient with written consent
Key exclusion criteria (4 listed)
- pregnant or breastfeeding patients
- patients known to have severe skin reactions to adhésives
- patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
- patients deprived of their liberty or under guardianship
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 |
|---|---|---|
| Patch validationUse of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature | Device | Connected patch validation |
Primary outcome
Concordance of blood pressure value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
Time frame: 36 hours maximum after the surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
Concordance of heart rate value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
Time frame: 36 hours maximum after the surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
Concordance of respiratory rate value measured by 2 different during the postoperative stay in the post-operative period in the post-anesthesia care unit
Time frame: 36 hours maximum after the surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
Concordance of arterial oxygen saturation value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia
Time frame: 36 hours maximum after the surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
Concordance of temperature value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit
Time frame: 36 hours maximum after the surgery
Comparison between temperature measured by conventional medical monitoring device and by connected patch
10 secondary outcomes
Concordance of blood pressure value measured by 2 different devices during anesthesia
Time frame: During anesthesia
Concordance of heart rate value measured by 2 different devices during anesthesia
Time frame: During anesthesia
Concordance of respiratory rate value measured by 2 different devices during anesthesia
Time frame: During anesthesia
Concordance of arterial oxygen saturation value measured by 2 different devices during anesthesia
Time frame: During anesthesia
Concordance of temperature value measured by 2 different devices during anesthesia
Time frame: During anesthesia
Blood pressure artifact
Time frame: From beginning of anesthesia to 36 hours
Heart rate artifact
Time frame: From beginning of anesthesia to 36 hours maximum after the surgery
Respiratory rate artifact
Time frame: From beginning of anesthesia to 36 hours maximum after the surgery
Arterial oxygen saturation artifact
Time frame: From beginning of anesthesia to 36 hours maximum after the surgery
Acceptability of connected patch
Time frame: During the surgery and 36 hours maximum after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 32978206Le Guen M, Squara P, Ma S, Adjavon S, Trillat B, Merzoug M, Aegerter P, Fischler M. Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit. BMJ Open. 2020 Sep 25;10(9):e040453. doi: 10.1136/bmjopen-2020-040453.
- Individual participant dataSharing planned: Yes. Data will be available in the Dryad repository
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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.
Marc FISCHLER, MD study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch validation in people with Anesthesia, run by CMC Ambroise Paré at 1 site in France.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 7 May 2021. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Concordance of blood pressure value measured by 2 different devices during the postoperative stay in the post-operative period in the post-anesthesia care unit (time frame: 36 hours maximum after the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344093, which also lists 1 linked publication.
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 7 May 2021.