Multifunctional Approach in Cardiac Surgery (TITANIC)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

Treatments: Behavioral: Multifunctional rehabilitation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05824598

06_08/02/2023

Details and patient eligibility

About

Postoperative pain and swallowing disorders are complex, multifactorial phenomenon that frequently occur after cardiac surgery. Preoperative anxiety and the interaction between sex and other sociocultural factors may predict greater sensitivity to postoperative pain, whereas the epidemiology and course of swallowing disorders has not been systematically investigated, along with the interaction between dysphagia, post-operative pain and emotional stress. Cardiac rehabilitation is a multifunctional intervention which may address all these functional domains, improving patients' prognosis.

The aim of the present study is to demonstrate the superiority of a multifunctional approach (OMT, systematic swallowing screening and specific treatment according to good clinical practice associated with psychological counseling) compared to local clinical practice in the management of pain and swallowing disorders.

Full description

The TITANIC trial will provide evidence on whether a multifunctional intervention systematically implemented in the cardiac rehabilitation setting will improve the clinical course and prognosis of patients with recent cardiac surgery.

The design is a randomized clinical trial with parallel group design. Patients aged over 18 undergoing elective cardiac surgery and admitted to IRCCS Fondazione Don Gnocchi, Santa Maria Nascente, Milan, for cardiac rehabilitation will be randomized to standard post-acute treatments (cardiovascular training, monitoring and logopedic treatment only in case of swallowing dysfunction) compared with an experimental approach which consists of osteopathic manipulative treatment (OMT) treatments, swallowing screen protocol, psychological assessment and counseling.

This study may help in the identification of a new diagnostic-therapeutic pathway in cardiac surgery patients that allows a reduction in the use of analgesics and anti-inflammatories and increases the early detection of swallowing disorders. Furthermore, by allowing an integrated assessment of emotional needs, it can have a positive effect in reducing the need for post-operative clinical visits and assessments in the medium to long term, improving the patients' quality of life.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (all the following must be satisfied):

• patients with recent cardiac surgery (within one month)
• without swallowing disorders already identified before discharge
• with the presence of chest pain (NRS>2).

Exclusion Criteria:

• patients who are unable to sign informed consent.
• patients with already known psychological/psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Treatment

Experimental group

Description:

The cases (active treatment) will be treated with an approach that includes osteopathic treatment for pain control (by the Osteopath Bruno Bordoni), systematic swallowing screening (Speech Therapist, Leone Stilo), psychological counseling (Psychologist, Eleonora Volpato, Giulia Novembre ). The duration of treatment will be that of hospitalization, on average about 3 weeks. The osteopathic treatment will last 5 sessions, while the counseling will have one session at the admission and one at the discharge and up to two sessions a week (variable according to individual needs); the swallowing screening will have one session at the admission and one at discharge and about two-three sessions a week (variable according to individual needs).

Treatment:

Behavioral: Multifunctional rehabilitation treatment

Controls

No Intervention group

Description:

Controls will follow good clinical practice (in this case systematic screening from a swallowing point of view will not be applied, nor will osteopathic treatment and systematic psychological counseling be considered).