Protocol summary

Study aim
Comparison of the effect of chest compression during exhalation with physical therapy using vibration and percussion methods on isolation indices in patients under mechanical ventilation.
Design
Eligible patients admitted to the special wards of Ayatollah Kashani Hospital, who are under mechanical ventilation for 48 hours. The sample size is 30 people in each group and 60 people in total.
Settings and conduct
Ayatollah Kashani Hospital and in 1401
Participants/Inclusion and exclusion criteria
Inclusion Having an age range of 18 to 70 years Having a tracheal tube No injuries (rib fracture, lung contusion) and chest tube Not undergoing chest surgery Connecting to a ventilator for 48 hours Failure to receive intratracheal suction within one hour before each procedure The mode of ventilator for patients is CPAP Exit : Receiving muscle paralyzing drugs Change in mechanical ventilation device settings
Intervention groups
The first group is subjected to suction without chest compression during exhalation and 3 hours later under suction with chest compression. During exhalation, the researcher applies unilateral pressure in the lower 1/3 of the chest using his hands, and at the end of each exhalation, the pressure is removed from the affected areas of the patient, and the airway secretions are suctioned for each of the studied units at a distance of 3 hours from each other. The day is done. Intervention group 2: First, they are subjected to suction without percussion and vibration physiotherapy, and 3 hours later, they are subjected to suction with percussion and vibration physiotherapy. Vital signs, rapid shallow breathing before the interventions, 5 and 25 minutes after the interventions are recorded in each group, and then the data are compared for both groups.
Main outcome variables
Indicators of isolation from mechanical ventilation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091215002861N18
Registration date: 2022-12-09, 1401/09/18
Registration timing: prospective

Last update: 2022-12-09, 1401/09/18
Update count: 0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chest compression during exhalation with physiotherapy by vibration and percussion methods on weaning index in mechanically ventilated patients
Public title
Investigating chest compressions during exhalation and physiotherapy using percussion and vibration methods on isolation indicators in mechanically ventilated patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Having an age range of 18 to 70 years Having a stable hemodynamic status Having a tracheal tube No injuries (rib fracture, lung contusion) and chest tube Not undergoing chest surgery Connecting to a ventilator for 48 hours Failure to receive intratracheal suction within one hour before each procedure The mode of ventilator for patients is CPAP
Exclusion criteria:
Receiving muscle paralyzing drugs during the research period Change in the settings of the mechanical ventilation device for any reason within the time frame of the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly allocated to either an intervention or a control group. Accordingly, a list of participants’ names was created and their names were numbered from one to sixty. Then, a random allocation software was used to randomly allocate numbers 1–60 to two groups. The fourth author independently generated allocation sequence and concealed it so that participants, statistical analyst, and the second and the third authors were blind to the sequence. For this purpose, we make our list of Participants and assign each participant a number. Again, we used a random number generator to place each participant in one of the two groups. The following steps were taken to select samples: 1. Preparing a list of all the Participants were enrolled from the databases of these hospitals; 2. A list of all Participants was prepared initially, and then each member was marked with a specific number (Assigned a sequential number to each Participants (1,2,3…60)). 3. Sample size was calculated at 32 according to the following criteria: (Ζ1- α/2 =1.96, α= 0.05, β= 0.1, σ= 6 and d= 5). 4. The samples were randomly selected by the random number generator software (the participants generated randomly without human interference). However, 30 Participants were recruited to each group (30 Participants ) to increase the study power. The fourth author independently generated the allocation sequence and concealed it, so that the participants, the statistical analysts, and the third author were blind to the sequence.
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
Shahrekord University of Medical Sciences and Health Services
Street address
Nursing department, Nursing and midwifery college, Rahmatie, Shahrekord,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2022-11-04, 1401/08/13
Ethics committee reference number
IR.SKUMS.REC.1401.127

Health conditions studied

1

Description of health condition studied
Comparison of the effect of chest compression during exhalation with physical therapy using vibration and percussion methods on isolation indices in patients under mechanical ventilation.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Indicators of separation of patients under mechanical ventilation from the ventilator
Timepoint
Indicators of separation of patients under mechanical ventilation from the ventilator
Method of measurement
Before the intervention5 and 25 minutes after the intervention

Secondary outcomes

1

Description
Assessment ofo2sat, rapid shallow breathing, blood pressure, pulse
Timepoint
Before the intervention, 5and 25 minutes after the intervention
Method of measurement
Checklist that includes assessment of o2sat, rapid shallow breathing, blood pressure, pulse

Intervention groups

1

Description
Intervention group: Compression of the chest during exhalation
Category
Diagnosis

2

Description
Physiotherapy group using vibration and precision method
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان آیت الله کاشانی
Full name of responsible person
دکتر رضا مسعودی
Street address
رحمتیه. دانشگاه علوم پزشکی شهرکرد
City
شهرکرد
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1411
Email
masoodi@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
دکتر رضا مسعودی
Street address
رحمتیه.دانشگاه علوم پزشکی شهرکرد
City
شهرکرد
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1411
Email
masoodi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Reza Masoudi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1411
Email
masoodi@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Reza Masoudi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
رحمتیه
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1411
Email
massoodi@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
فاطمه عظیمی سرتشنیزی
Position
دانشجوی کارشناسی ارشد پرستاری گرایش ویژه
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Chahar Mahal Bakhtiari province, Shahrekord, Shariati street, corner of alley 11, second floor, unit 5
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815875481
Phone
+98 38 3334 8663
Email
fatemhazimi62@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is not a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...