Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824598
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-03-13
Brief Title:
Multifunctional Approach in Cardiac Surgery
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
OsteopaThic logopedIc and Psychological Assessment To Improve Outcome in pAtieNts undergoIng Cardiac Surgery a Randomized Clinical Trial TITANIC Trial
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TITANIC
Brief Summary:
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None