Breathing Exercise for Rib Fracture

NCT06222333 | Recruiting

• 1 other identifier: KastamonuU1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rib Fractures; Spirometry

Outcome Measures

Primary Outcomes (1)

• FEV1, FVC, FEV1/FVC results on day 7

  FEV1, FVC, FEV1/FVC

  7 days

Secondary Outcomes (2)

• Number of Participants with Pneumonia

  7 days

• FEV1, FVC, FEV1/FVC results on day 2

  2 days

Study Arms (2)

Respiratory physiotherapy group

EXPERIMENTAL

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

Routine treatment group

ACTIVE COMPARATOR

Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.

Drug: Conservative Treatment

Interventions

Respiratory physiotherapy BEHAVIORAL

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.

Also known as: Triflow

Respiratory physiotherapy group

Conservative Treatment DRUG

Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.

Also known as: Control

Routine treatment group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu University

Kastamonu, 37150, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

İsmail Dal, MD

CONTACT

+905446533224; drismaildal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Literally: Doctor Teaching Member

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 24, 2024
• Study Start: November 13, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available permanently on 1.4.2025
• Access Criteria: Upon reasonable request principal investigator will share date

Locations

TU (1)