Respiratory Physiotherapy in Mechanical Ventilation
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
breath exercises
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring respiratory physiotherapy
Eligibility Criteria
Inclusion Criteria:
- weaning period of patients in invasive mechanical ventilation
- patients in stable hemodynamic parameters
Exclusion Criteria:
- under 18 years old
- pregnant
- non-cooperative
Sites / Locations
- Mugla Sıtkı Kocman University Reasearch and Treaninig Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPT
Arm Description
Outcomes
Primary Outcome Measures
weaning success
effect of respiratory physiotherapy as diaphragmatic exercise of weaning
Secondary Outcome Measures
Compliance
effect of diaphragmatic exercise on compliance, diaphragmatic movement
diaphragmatic movement
effect of diaphragmatic exercise on diaphragmatic movement
arterial blood gas
effect of diaphragmatic exercise on diaphragmatic movement
Full Information
NCT ID
NCT04670939
First Posted
August 18, 2019
Last Updated
December 13, 2020
Sponsor
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT04670939
Brief Title
Respiratory Physiotherapy in Mechanical Ventilation
Official Title
the Effect of Respiratory Physiotherapy to Weaning in Invasive Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to evaluate the effect of respiratory physiotherapy that is breathing exercise during weaning on ventilated patients in ICU.
Detailed Description
Respiratory physiotherapy is a treatment approach to increase ventilation and function in patients with acute and chronic problems and to reduce respiratory work and dyspnea.Airway cleaning techniques, lung volume-enhancing approaches, thoracic mobilization, positioning, breathing exercises and inhalation therapy are among the strategies used.
In patients with invasive MV support, respiratory physiotherapy is the position, tracheal cleaning and inhalation therapy when necessary. But breathing exercises are not indicated in the acute phase. In the process of weaning, inspiratory muscle training and breathing exercises can be used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
respiratory physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
breath exercises
Intervention Description
diaphragmatic breathing exercise that used during weaning is the respiratory physiotherapy
Primary Outcome Measure Information:
Title
weaning success
Description
effect of respiratory physiotherapy as diaphragmatic exercise of weaning
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Compliance
Description
effect of diaphragmatic exercise on compliance, diaphragmatic movement
Time Frame
1-7 days
Title
diaphragmatic movement
Description
effect of diaphragmatic exercise on diaphragmatic movement
Time Frame
1-7 days
Title
arterial blood gas
Description
effect of diaphragmatic exercise on diaphragmatic movement
Time Frame
1-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
weaning period of patients in invasive mechanical ventilation
patients in stable hemodynamic parameters
Exclusion Criteria:
under 18 years old
pregnant
non-cooperative
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan Gürsoy
Organizational Affiliation
Muğla Sıtkı Koçaman University, Training And Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Reasearch and Treaninig Hospital
City
Mugla
ZIP/Postal Code
48000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Respiratory Physiotherapy in Mechanical Ventilation
We'll reach out to this number within 24 hrs