Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients

Not Applicable

Recruiting

• Conditions: Spontaneous Breathing Trial in ICU; Spontaneous Breathing Trial

• Registration Number: NCT07163247
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-24
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2025-11
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Behavioral responses	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.	Behavioral responses will be assessed using the Motor Activity Assessment Score (MAAS). Data will be analyzed as both continuous and categorical variables.; Continuous variable: mean MAAS score (range 0-6). Categorical variables: Sedated (MAAS 0-2); Cooperative (MAAS = 3); Agitated (MAAS 4-6).
Subjective Psychological response	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.	Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).
Objective Psychological Response	During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Crying or anger for more than five minutes (yes/no).

Secondary Outcome Measures

Name	Time	Method
Signs of respiratory distress - heart rate	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Average heart rate measured in beats per minute (bpm).
Signs of respiratory distress - blood pressure	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Average blood pressure measured in millimeters of mercury (mmHg).
Signs of respiratory distress - respiratory rate	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Average respiratory rate measured in breaths per minute.
Signs of respiratory distress - oxygen saturation	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Average peripheral oxygen saturation measured in percent.
Spontaneous breathing trial outcome	After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Completion of spontaneous breathing trial (Yes/No).
Duration of spontaneous breathing trial	After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	Total duration of completed spontaneous breathing trial measured in minutes.
Adverse events	From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.	All adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), as defined by Good Clinical Practice (GCP), will be recorded.
Extubation within 24 hours	Within 24 hours from Day 1 of measurement.	Extubation is defined as removal of the endotracheal tube after the physician's evaluation and confirmation of readiness. Success is defined as removal of the tube within 24 hours and is measured as yes/no.
Experience of using robotic pet	3 days after extubation.	A semi-structured interview will be conducted with participants in the experimental arm. The interview will include the following four domains: 1. Experiences with the spontaneous breathing trials.; 2. Experiences with robotic pet companionship.; 3. Perceived helpfulness of the robotic pet in alleviating anxiety.; 4. Suggestions for future use of the robotic pet.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan