Spontaneous Breathing Trial in ICUNCT07163247
Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients
A study testing Robotic pet (PARO) companionship in people with Spontaneous Breathing Trial in ICU and Spontaneous Breathing Trial, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Breathing Trial in ICU, Spontaneous Breathing Trial
- What is being tested?
- Robotic pet (PARO) companionship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chia-Hui Chen, PhD, +886-2-23123456 ext. 288438, cherylchen@ntu.edu.tw
About this study
Official title: Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients
This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.
Read the 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.
- Being tested
- Robotic pet (PARO) companionship
- Keywords
- spontaneous breathing trials, Pet-robotic intervention, anxiety, Robot assisted intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic pet (PARO) companionshipBehavioural
Also called PARO@ICU
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 the intervention.
Assessment: Outcome measurements are conducted during the intervention. If extubated successfully, a semi-structured interview is conducted three days later.
Early termination: The intervention is stopped if the participant becomes clinically unsuitable for further SBTs or experiences a serious adverse event (e.g., device dislodgement).
Additional information: After each SBT, PARO is sterilized and stored in a sealed container in the patient's room.
| Study group | Role | What they receive |
|---|---|---|
| Robotic pet (PARO) companionship | Experimental | Participants will receive companionship from a robotic baby seal pet (PARO) during their spontaneous breathing trials. The intervention will be administered continuously throughout the entire duration of the spontaneous breathing trials period or until the participant meets predefined early termination criteria. Receives: Behavioral: Robotic pet (PARO) companionship |
| Standard care | No intervention | Participant in this arm will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral responses
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).
Measured: 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
Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).
Measured: 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
Crying or anger for more than five minutes (yes/no).
Measured: During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Secondary outcomes (9)
Signs of respiratory distress - heart rate
Average heart rate measured in beats per minute (bpm).
Measured: 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
Average blood pressure measured in millimeters of mercury (mmHg).
Measured: 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
Average respiratory rate measured in breaths per minute.
Measured: 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
Average peripheral oxygen saturation measured in percent.
Measured: 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
Completion of spontaneous breathing trial (Yes/No).
Measured: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Duration of spontaneous breathing trial
Total duration of completed spontaneous breathing trial measured in minutes.
Measured: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Adverse events
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.
Measured: From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Extubation within 24 hours
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.
Measured: Within 24 hours from Day 1 of measurement.
Experience of using robotic pet
A semi-structured interview will be conducted with participants in the experimental arm. The interview will include the following four domains:
- Experiences with the spontaneous breathing trials.
- Experiences with robotic pet companionship.
- Perceived helpfulness of the robotic pet in alleviating anxiety.
- Suggestions for future use of the robotic pet.
Measured: 3 days after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Breathing Trial in ICUStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163247
- Sponsor's protocol ID
- 202505120RINC
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07163247
- Acronym / sponsor ID
- 202505120RINC
- Keywords
- spontaneous breathing trials, Pet-robotic intervention, anxiety, Robot assisted intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic pet (PARO) companionship | Experimental | Behavioral: Robotic pet (PARO) companionshipParticipants will receive companionship from a robotic baby seal pet (PARO) during their spontaneous breathing trials. The intervention will be administered continuously throughout the entire duration of the spontaneous breathing trials period or until the participant meets predefined early termination criteria. |
| Standard care | No intervention | –Participant in this arm will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic pet (PARO) companionshipAlso: PARO@ICUThe 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 the intervention. Assessment: Outcome measurements are conducted during the intervention. If extubated successfully, a semi-structured interview is conducted three days later. Early termination: The intervention is stopped if the participant becomes clinically unsuitable for further SBTs or experiences a serious adverse event (e.g., device dislodgement). Additional information: After each SBT, PARO is sterilized and stored in a sealed container in the patient's room. | Behavioural | Robotic pet (PARO) companionship |
Primary outcome
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.
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
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.
Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).
Objective Psychological Response
Time frame: 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).
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic pet (PARO) companionship in people with Spontaneous Breathing Trial in ICU and Spontaneous Breathing Trial, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.