Menu
Recruiting NCT07163247

Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients

No phase Interventional Spontaneous Breathing Trial in ICU Spontaneous Breathing Trial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic pet (PARO) companionship.
Who it may be relevant to
Registry conditions: Spontaneous Breathing Trial in ICU, Spontaneous Breathing Trial. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients

Overview

This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.

Detailed description

This study aims to investigate the effectiveness of pet robotic intervention during spontaneous breathing trials in adult patients admitted to medical intensive care units. The study explores whether this intervention can alleviate patients' anxiety during the weaning process, as well as enhance successful spontaneous breathing trials and facilitate further extubation.

Interventions

  • Behavioral Robotic pet (PARO) companionship
    The intervention is composed of the following components: Duration: Robotic pet companionship lasting 30-120 minutes, depending on clinical goals during each spontaneous breathing trial (SBT). Preparation and interaction: PARO is introduced 30 minutes before each SBT to establish emotional connection. Study staff will briefly introduce its interactive features, including responding to stroking, gentle tapping, head movements, and eye blinking. Participants may interact freely with PARO during

Primary outcome measures

  • Behavioral responses [Time frame: Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 until extubation, intensive care unit discharge, or early termination.]
  • Subjective Psychological response [Time frame: Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Objective Psychological Response [Time frame: During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
Secondary outcome measures (9)
  • Signs of respiratory distress - heart rate [Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Signs of respiratory distress - blood pressure [Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Signs of respiratory distress - respiratory rate [Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Signs of respiratory distress - oxygen saturation [Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Spontaneous breathing trial outcome [Time frame: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Duration of spontaneous breathing trial [Time frame: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Adverse events [Time frame: From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Extubation within 24 hours [Time frame: Within 24 hours from Day 1 of measurement.]
  • Experience of using robotic pet [Time frame: 3 days after extubation.]

Eligibility criteria

Inclusion criteria

  • Aged 18 years or older with clear consciousness.
  • Mechanical ventilation for more than 72 hours.
  • Previously failed the first spontaneous breathing trial and is clinically ready to undergo a second spontaneous breathing trial.

Exclusion criteria

  • Multidrug-resistant organism infection.
  • Requiring airborne infection isolation precautions (e.g., COVID-19).
  • Immunodeficiency (absolute neutrophil count < 500 cells/mL).
  • Richmond Agitation-Sedation Scale (RASS) less than -1.
  • Patient with a tracheostomy.
  • Subjects with implanted cardiac devices (e.g., permanent pacemaker, implantable cardioverter defibrillators)
  • Known allergy to the fur of the robotic pet.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07163247 · 202505120RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗