Validation of a Connected Patch, an Alternative to Conventional Monitoring

NCT04344093 | Withdrawn

• 1 other identifier: 2019/11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  36 hours maximum after the surgery

Secondary Outcomes (10)

• Concordance of blood pressure value measured by 2 different devices during anesthesia

  During anesthesia

• Concordance of heart rate value measured by 2 different devices during anesthesia

  During anesthesia

• Concordance of respiratory rate value measured by 2 different devices during anesthesia

  During anesthesia

• Concordance of arterial oxygen saturation value measured by 2 different devices during anesthesia

  During anesthesia

• Concordance of temperature value measured by 2 different devices during anesthesia

  During anesthesia

Study Arms (1)

Connected patch validation

EXPERIMENTAL

Device: Patch validation

Interventions

Patch validation DEVICE

Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature

Connected patch validation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

Hopital FOCH

Suresnes, France

Location

Related Publications (1)

• 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.

  PMID: 32978206 DERIVED

Study Officials

• Marc FISCHLER, MD

  Hopital Foch

  STUDY CHAIR

Study Design

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

Model Details: Connected patch validation

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: December 29, 2020
• Primary Completion: May 29, 2022
• Study Completion: June 3, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After publication in a peer-review journal .No limit in time
• Access Criteria: No criteria

Locations

FR (1)