Respiratory Physiotherapy in Mechanical Ventilation | NCT04670939

Studies
Respiratory Physiotherapy in Mechanical Ventilation

NCT04670939

Sponsor

Muğla Sıtkı Koçman University

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Respiratory Failure

Interventions

breath exercises

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2018Actual

Primary Completion Date

Mar 18, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Aug 18, 2019

First Submission Date that Met QC Criteria

Dec 13, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPT	Experimental		Procedure: breath exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
breath exercises	Procedure	diaphragmatic breathing exercise that used during weaning is the respiratory physiotherapy	SPT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weaning success	effect of respiratory physiotherapy as diaphragmatic exercise of weaning	1-7 days

Secondary Outcomes

Measure	Description	Time Frame
Compliance	effect of diaphragmatic exercise on compliance, diaphragmatic movement	1-7 days
diaphragmatic movement	effect of diaphragmatic exercise on diaphragmatic movement

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Canan Gürsoy	Muğla Sıtkı Koçaman University, Training And Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mugla Sıtkı Kocman University Reasearch and Treaninig Hospital		Muğla		48000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided