Application of Wearable Technology in High-risk Surgical Patients in the Perioperative Period

NCT05642988 | Completed FDA Device

• 1 other identifier: 1/378/2207
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Unrecognised changes in patients' vital signs after surgery can result in preventable complications. Current standard practice includes routine monitoring of patient vital signs up until hospital discharge. Upon discharge from hospital, all forms of routine vital sign monitoring ceases. The availability and use of wearable technology in healthcare is increasing rapidly. The role of wearable technology in the remote monitoring of patients at high-risk of post-operative complications and hospital readmission after discharge from hospital is unclear. This pilot study is aimed to assess the feasibility of using wearable technology in patients recovering from major intracavity surgery after hospital discharge in the Irish healthcare setting.

Conditions

Adult ALL; Surgery; Anesthesia; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Compliance with wearable technology

  Assess compliance with remote monitoring in the first 30-days after hospital discharge following intra-abdominal or pelvic surgery. Compliance will be defined as wearing the biosensor for at least 20 hours per day.

  30-days

Secondary Outcomes (5)

• Unplanned hospital admission or GP visits

  30-days after hospital discharge

• Heart rate

  30-days after hospital discharge

• Temperature

  30-days after hospital discharge

• Respiratory Rate

  30-days after hospital discharge

• Quality of recovery score (QoR15)

  30-days after hospital discharge

Study Arms (1)

Adult patients being discharged from hospital following intra-abdominal or pelvic surgery

Patient compliance with wearable biosensor monitoring after major intracavity surgery. The remote monitoring is made up of a wearable biosensor and a data-enabled relay device which will detect vital sign observations (ECG, heart rate, temperature and respiratory rate) and a health status assessment questionnaire.

Device: LifeSignals 1AX Biosensor

Interventions

LifeSignals 1AX Biosensor DEVICE

Biosensor worn by patients for 30-days after intra-abdominal or pelvic surgery on discharge from hospital

Adult patients being discharged from hospital following intra-abdominal or pelvic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients recovering from major intra-cavity abdominal surgery being discharged from the Mater Misericordiae University Hospital in Dublin, Ireland.

You may qualify if:

• Over 18 years of age
• Scheduled to undergo or recently undergone major intra-cavity abdominal surgery
• Able to give informed written consent to participate

You may not qualify if:

• Deemed unfit for surgery
• Unable or unwilling to comply with remote monitoring for any reason
• Unable or unwilling to fill in a questionnaire in English

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead
• Health Service Executive, Ireland: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Postoperative Complications

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)