Effects of IMT on Clinical Outcomes in Cardiac Surgery

April 15, 2022 updated by: Hong Liu, Nanjing Medical University

Effects of Inspiratory Muscle Training on Clinical Outcomes in Individuals With Cardiac Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative intubation time
Time Frame: 5 days after surgery
5 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative length of stay
Time Frame: 30 days after surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT-Jph 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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