Breathing Exercise for Rib Fracture

January 15, 2024 updated by: İsmail DAL, Kastamonu University

Can Breathing Exercise Reduce Pulmonary Complications in Rib Fractures: Randomized Prospective Study

Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. In our study, patients with rib fractures will be divided into two groups. In the control group, standard treatment consisting of routine analgesic treatments will be applied. In the other group, respiratory physiotherapy will be applied with triflu for 8 hours a day. At the end of the study, pulmonary complications in both groups will be compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients between the ages of 18 and 100 who will apply to our hospital due to rib fractures between April 2024 and April 2025 will be evaluated. Patients who meet the inclusion criteria will be included in the study. Patients will be divided into two groups using randomization blocks. Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. In the other group of patients, in addition to conservative treatment, triflow breathing exercise will be applied for 8 hours a day. Respiratory function test pain scores and pulmonary complications of patients in the two groups will be compared statistically.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Isolated thoracic injury within 24 hours
  • Age between 18-100

Exclusion Criteria:

  • Pneumothorax and hemothorax requiring intervention at admission
  • Injury severity index >16
  • COPD, Atshma
  • Extrathoracic trauma

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory physiotherapy group
In this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour
Behavioral: Respiratory physiotherapy
In this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour.
Other Names:
  • Triflow
Active Comparator: Routine treatment group
Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.
Drug: Conservative Treatment
Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1, FVC, FEV1/FVC results on day 7
Time Frame: 7 days
FEV1, FVC, FEV1/FVC
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Pneumonia
Time Frame: 7 days
Clinical and radiological diagnosis of pneumonia
7 days
FEV1, FVC, FEV1/FVC results on day 2
Time Frame: 2 days
FEV1, FVC, FEV1/FVC
2 days

Collaborators and Investigators

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

Sponsor

Kastamonu 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KastamonuU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes

IPD Sharing Time Frame

Data will be available permanently on 1.4.2025

IPD Sharing Access Criteria

Upon reasonable request principal investigator will share date

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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