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Investigating the effect of high-frequency Chest Wall oscillation (HFCWO) on respiratory outcomes of intubated patients admitted to the internal-surgery intensive care unit

Protocol summary

Study aim
Determining the effect of high-frequency chest wall oscillation in non-intubated patients admitted to the special care department of Erfan Niayesh Hospital on the respiratory outcome
Design
Clinical trial with a control group, parallel, non-blind, randomized, phase 3 on 100 patients (50 people in each group). A simple tap or line randomization method will be used and each client will be placed in the intervention or control group by tossing a coin, tap and line.
Settings and conduct
The study will be conducted in Erfan Niayesh Hospital, Tehran, on non-intubated patients admitted to the general intensive care unit. Adult patients between the ages of 20 and 70 who are not intubated and hospitalized of both genders will be included in the study. The patients will be divided into two groups: both groups will receive the necessary treatments for recovery. are placed specially and the second group will use high frequency chest wall oscillation in addition to standard chest physiotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ICU patients aged 20 to 70 years who are completely bed rested and have systemic weakness and need physical therapy are included in the study. Exclusion criteria: pregnancy, history of chronic lung disease, brain pathology, spinal fracture and pathology, sepsis, pneumonia at the beginning of the study, intubated patients, gastrointestinal bleeding, and lack of consent to enter the study.
Intervention groups
Both groups will receive the necessary treatments for recovery. The first group will undergo standard chest physiotherapy in the intensive care unit, and the second group will use high-frequency chest wall oscillation in addition to standard chest physiotherapy.
Main outcome variables
The respiratory outcome in the present study includes the rate of pneumonia, length of hospitalization and the need for mechanical ventilation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230614058485N1
Registration date: 2023-06-20, 1402/03/30
Registration timing: prospective

Last update: 2023-06-20, 1402/03/30
Update count: 0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Zeinab Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 742 0978
Email address
alizadeh.md6010@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of high-frequency Chest Wall oscillation (HFCWO) on respiratory outcomes of intubated patients admitted to the internal-surgery intensive care unit
Public title
Investigating the effect of high-frequency Chest Wall oscillation (HFCWO) on respiratory outcomes of intubated patients admitted to the internal-surgery intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient aged between 20 to 70 years old, who are complete bed rest with generalized systemic illness and need chest physiotherapy.
Exclusion criteria:
Pregnancy History of chronic pulmonary disease Brain pathology Spine fracture and pathology Sepsis Pneumonia at first step Intubated at first step Gastrointestinal bleeding Lack of consent to enter the study
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
A simple tap or line randomization method will be used and each client will be placed in the intervention or control group by tossing a coin, tap and line.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences., Shahid Arabi Street., Shahid Shahriari Square., Tehran Town
City
Tehran
Province
Tehran
Postal code
صندوق پستی: 19857174
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SBMU.MSP.REC.1402.103

Health conditions studied

1

Description of health condition studied
Respiratory outcome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Peneumonia
Timepoint
During hospitalization in the intensive care unit
Method of measurement
Nosocomial pneumonia or hospital-acquired pneumonia (HAP) criteria

Secondary outcomes

empty

Intervention groups

1

Description
The first group (control) will undergo standard chest physiotherapy in the intensive care unit, and the second group (intervention) will also use HFCWO in addition to standard chest physiotherapy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Erfan Niayesh Hospital
Full name of responsible person
Zeinab Alizadeh
Street address
No 17, Bahar Street., Kabiri Tameh Blvd., West prayer highway., Tehran Town
City
Tehran
Province
Tehran
Postal code
1476919491
Phone
+98 21 4979 6000
Fax
+98 21 4461 0617
Email
info@niayeshhospital.ir
Web page address
https://niayeshhospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Abbas Arabi Street (Parvaneh)., Yemen Street., Shahid Chamran highway.,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
info@sbmu.ac.ir
Web page address
http://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
Critical Care Specialist Assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 30, Simin Alley., North Jamalzadeh Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
1418633641
Phone
+98 21 6530 0814
Email
alizadeh.md6010@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
Critical Care Specialist Assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 30, Simin Alley., North Jamalzadeh Street.,Tehran Town
City
Tehran
Province
Tehran
Postal code
1418366341
Phone
+98 21 6530 0814
Email
alizadeh.md6010@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
Critical Care Specialist Assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 30, Simin Alley., North Jamalzadeh Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
1418366341
Phone
+98 21 6530 0814
Email
alizadeh.md6010@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All non-identifiable information and data of individuals and analyzes will be provided for publication after the end of the study
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
Email: alizadeh.md6010@gmail.com
What processes are involved for a request to access data/document
A valid letter of introduction from a recognized scientific center and university to be sent by email. After inquiring with the introducing center, the requested information will be emailed to that center.
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