Pets Enhancing Therapeutics in Intensive Care Units

N/ANot Yet RecruitingNCT07159568

University Hospital, Clermont-Ferrand21 enrolled

Overview

Intensive Care Units (ICUs) are well known for their therapeutic and environmental aggressiveness. Current recommendations for the management of critically ill patients, including the "ABCDEF bundle," emphasize family engagement and liberal visitation policies for relatives and loved ones, with the aim of improving patient well-being during their ICU stay. In France, half of all households own a pet. This close relationship between humans and animals explains why animals have long been involved in medical care. The earliest known use of animals in medicine dates back to the 9th century in Belgium, where they were used to assist individuals with mental illness. More recently, companion animal-assisted interventions have attracted growing interest due to their potential diagnostic and/or therapeutic value, as they may enhance the patient experience during hospitalization. The feasibility, safety, and potential benefits of pet visitation policies have mainly been assessed in conventional hospital wards, but remain understudied in the ICU setting. In France, to our knowledge, only three hospitals have allowed pet visits in the ICU, and these occurred outside of any research protocol. The study primary objective is to assess the feasibility of companion dog visits in three medical-surgical ICUs.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Intensive Care Unit (ICU) Patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient aged 18 years or older, * Admitted to one of the participating ICUs at Clermont-Ferrand University Hospital (Estaing Adult ICU, Montpied Medical-Surgical ICU, or Montpied Neuro-ICU) with an expected ICU stay of 48 hours or more, * Owner of a companion dog, with family members or relatives able to bring the dog to the ICU. Exclusion Criteria: Patient-related exclusion criteria: * Refusal by the patient or by their family/relatives to participate, * Lack of affiliation with the French national health insurance system (Sécurité Sociale), * Patient deprived of liberty or under legal protection (guardianship, curatorship, or judicial safeguard), * Pregnant or breastfeeding patient, * Agitated patient, defined as a Richmond Agitation-Sedation Scale (RASS) score \> 0 (monitored every four hours according to current standard practice), * Patient with immunosuppression, defined as: blood neutrophil count \< 0.5 G/L, ongoing or recent (within the past month) treatment for solid or hematologic cancer (e.g., chemotherapy, radiotherapy, cell therapy), or receiving immunosuppressive drugs (including organ transplant recipients or corticosteroid therapy for more than two weeks), * Patient with known colonization by multidrug-resistant bacteria (as routinely assessed upon ICU admission and weekly thereafter), * Patient with one or more open wounds or injuries that cannot be covered with a dressing. Dog-related exclusion criteria: * Dog belonging to category 1 or 2 breeds considered dangerous under current French regulations, * Dog that never leaves the home environment, * Dog with an incomplete vaccination status, * Dog with a known transmissible disease.

Outcomes

Primary Outcomes

Success of the pet dog visit

The success of the pet dog visit is defined as the entry of the animal into the patient's ICU room under the conditions specified in the study protocol

Time frame: Immediately after the intervention

Secondary Outcomes

Patient-related safety events regarding inconvenience or harm

Any inconvenience or harm to the patient, regardless of nature (including accidental dislodgement or removal of medical equipment/devices such as tracheal tubes, catheters, drains, etc.)

Time frame: Immediately after the intervention

Patient-related safety events regarding infections

New colonization with multidrug-resistant organisms (as assessed upon ICU admission and weekly thereafter); and new ICU-associated infections (as routinely screened according to standard care)

Time frame: ICU discharge (within a maximum of 28 days)

Dog-related events regarding aggression or behavioral issues

Any display of aggression or behavioral issues (as defined by the participating veterinarian, e.g., stupor, withdrawal, uncontrolled barking, urination or defecation) during the ICU visit, regardless of whether the dog ultimately entered the patient's room.

Time frame: Immediately after the intervention

Staff-related events regarding inconvenience or harm

Any inconvenience or harm to a member of the healthcare team, regardless of nature (e.g., injury, hygiene issues, noise, or behavioral disturbance) during the ICU visit, regardless of whether the dog ultimately entered the patient's room.

Time frame: Immediately after the intervention

Visit conditions in the case of success (excluding the safety criteria listed above)

Precise duration of the visit in the patient's room (maximum of 15 minutes, as per protocol), any direct contact between the patient and the dog, and the nature of such interaction.

Time frame: Immediately after the intervention

Reasons for potential visit failure (defined as the inability to bring the animal into the patient's ICU room)

Reasons are defined as : * Non-compliance with local hygiene guidelines and pre-/intra-visit checklists, as developed specifically for this protocol in collaboration with the hospital's infection control team (CLIN). * Non-compliance with local veterinary regulations and pre-visit veterinary checklists as defined in the study protocol (e.g., vaccination status, parasite control, and regular veterinary follow-up). * Patient agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score \> 0 (monitored every 4 hours per standard practice), before or during the visit. * Any other reason preventing the animal from entering the ICU or the patient's room before or during the visit (including patient discharge from ICU before the visit could be scheduled).

Time frame: Immediately before the intervention

Pre-visit ICU staff satisfaction-related survey

Pre-visit survey of ICU staff (including all clinical and non-clinical personnel such as physicians, nurses, therapists, hygiene and cleaning staff, administrative assistants, and supervisors) to assess their opinions and any potential concerns regarding the visit.

Time frame: Immediately before the intervention

Post-visit ICU staff satisfaction-related survey

Post-visit survey of the same ICU staff to assess their opinion and level of satisfaction.

Time frame: Immediately after the intervention

Post-visit satisfaction survey of the patient's relative(s) who accompanied the dog

Time frame: Immediately after the intervention

Patient satisfaction survey

Time frame: ICU discharge (within a maximum of 28 days)

Pets Enhancing Therapeutics in Intensive Care Units

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts