Effects of IMT on Clinical Outcomes in Cardiac Surgery

• Sponsor: Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04444362
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

Individuals who underwent cardiac surgery may experience anesthesia, intracardiac operation, cardiopulmonary bypass and mechanical ventilation, which will result in a lot of injuries. Inspiratory Muscle Training (IMT) is a regimen of breathing exercises that aim to strengthen the respiratory muscles and make it easier for a person to breathe. The aim of this study was to evaluate the efficacy of preoperative IMT on e clinical outcomes in patients with cardiac surgery.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Device: Inspiratory Muscle Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: Due to the nature of this research, we could not keep the participants blind to group assignment, but the study staff and statistical analyses were all blind to patient allocation during datacollection
• Primary Purpose: Prevention
• Official Title: Effects of Inspiratory Muscle Training on Clinical Outcomes in Individuals With Cardiac Surgery: A Randomized Controlled Trial
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inspiratory Muscle Training The Inspiratory Muscle Training group received respiratory muscle training, in addition to routine preparation, including laboratory and radiological examinations and preoperative education.	Device: Inspiratory Muscle Training; IMT underwent 5 days of 30 breaths twice daily at 50% (+5% increase each week) of maximum inspiratory pressure (MIP)
No Intervention: Control The control group received routine preparation, including laboratory and radiological examinations and preoperative education.

Outcome Measures

Primary Outcome Measures

1. Postoperative intubation time [5 days after surgery]

Secondary Outcome Measures

1. Postoperative length of stay [30 days after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult men and women

• Elective cardiac surgery

• Cardiac surgery on cardiopulmonary bypass

Exclusion Criteria:

• Individuals with neurological diseases that may make it impossible to perform IMT

• Emergency cardiac surgery

• Cardiac surgery without cardiopulmonary bypass

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

• Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Liu, Investigator of Cardio-Thoracic Surgery, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04444362
• Other Study ID Numbers: IMT-Jph 2020
• First Posted: Jun 23, 2020
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Apr 25, 2022