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Postbariatric EArly Discharge Controlled by Healthdot (PEACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754893
Recruitment Status : Completed
First Posted : February 15, 2021
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Philips Electronics Nederland B.V. acting through Philips CTO organization

Study Description
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Brief Summary:
This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of care bariatric surgery. The difference between both recovery paths is that half of the patients will get the standard of care by staying one night in the hospital before returning home (group B), while the other half will receive a Healthdot directly after surgery and leave the hospital on the same day (evening) (group A). 200 patients will be recruited and can choose whether they want to be assigned to the the regular recovery path or receive a Healthdot and leave the hospital on the same day. If they have no preference they will be randomly assigned to one of the two groups. Patients in the outpatient recovery group will wear the Healthdot for 7 days at home and vital signs (heart rate and respiratory rate, together with context data on activity and posture) will be transmitted to the hospital to monitor recovery. The study is mainly designed to investigate if the clinical outcome in both groups is equal (non-inferiority) based on a combined outcome measures like 30 days readmission rate and patient satisfaction.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Device: Healthdot application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Postbariatric EArly Discharge Controlled by Healthdot (PEACH)
Actual Study Start Date : February 22, 2021
Actual Primary Completion Date : December 25, 2021
Actual Study Completion Date : December 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Healthdot directly after surgery and leave the hospital on the same day (evening) (group A)
 Device: Healthdot application
Healthdot device is applied on subject's chest after surgery
No Intervention: Group b
Standard of care by staying one night in the hospital before returning home (group B)


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: Within 30 days after primary surgery ]
    Mortality will be determined from the patient medical record

  2. Severe postoperative complications (Clavien-Dindo IIIb or higher) [ Time Frame: Within 30 days after primary surgery ]
    Severe postoperative complications will be determined from the patient medical record

  3. Readmission (at least one night in hospital) [ Time Frame: Within 30 days after primary surgery ]
    Readmission will be determined from the patient medical record

  4. Mild complications (Clavien-Dindo II and IIIa) [ Time Frame: Within 30 days after primary surgery ]
    Mild complications will be determined from the patient medical record

  5. Prolonged length of stay (3 days or more in hospital) [ Time Frame: Within 30 days after primary surgery ]
    Prolonged length of stay will be determined from the patient medical record


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (equal or above 18)
  • Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team
  • Willing and able to sign informed consent form
  • Able to understand instructions
  • In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)
  • An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.

Exclusion Criteria:

  • Patients of psychiatric wards, inmates of prisons, or other state institutions
  • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  • Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (Left lower rib) where the Healthdot needs to be placed
  • Known allergy for the tissue adhesive used in the Healthdot (white band-aid)
  • Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
  • Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
  • Expected participation less than 8 days
  • Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
  • Patients with antibiotic resitant infections (e.g. MRSA)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754893


Locations
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Netherlands
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Philips Electronics Nederland B.V. acting through Philips CTO organization
Investigators
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Principal Investigator: Simon Nienhuijs Catharina Hospital, Eindhoven, The Netherlands
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philips Electronics Nederland B.V. acting through Philips CTO organization
ClinicalTrials.gov Identifier: NCT04754893    
Other Study ID Numbers: ICBE-2-36455
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No