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Study of the Effect of Manual Hyperinflation and Postural Drainage on Respiratory Indices in Mechanical Ventilation Patients in Intensive Care Units

Protocol summary

Study aim
the effect of manual hyperinflation and postural Drainage on respiratory parameters of mechanical ventilation patients
Design
80 patients were randomized, parallel to the control and intervention groups
Settings and conduct
This study will be done in the Imam Khomeini Hospital in Ilam. Patients will be randomly divided into intervention and control groups and respiratory parameters will be measured before and after the intervention in hospitalized patients.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients older than 18 years and less than 60 years old, positive end expiratory pressure 7.5 cm H2O, endotracheal Intubation, attached to ventilator in volumetric mod for 48 hours, stable hemodynamic status, no chest tube, chest trauma or: pneumothorax, Embolism, subcutaneous emphysema, burns, no pregnancy, obesity, No use of cardiac pacemaker. Exclusion criteria: receiving mucolytic and cramping drugs, starting, discontinuing or changing bronchodilator expansion agents, changes in mechanical ventilation settings, bronchospasm, Increased intracranial pressure
Intervention groups
Intervention group: first day, respiratory parameters ( before routine suctioning and 5, 10 and 25 minutes after Routine suctioning) will be recorded. Then, during the next day before Any time suction, manual dilatation techniques and Postural drainage will be recorded. Then, respiratory parameters (5, 10 and 25 minutes after intervention) will be recorded. control group: In the first 24 hours, patients will be suctioned as needed and respiratory parameters (before routine suction and 5, 10 and 25 minutes after routine suctioning) and during the next day, Required suctioning is performed without manual dilatation and postural drainage and respiratory parameters (5, 10 and 25 minutes after suctioning)will be recorded.
Main outcome variables
Respiratory indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190124042482N1
Registration date: 2019-08-26, 1398/06/04
Registration timing: retrospective

Last update: 2019-08-26, 1398/06/04
Update count: 0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Sajad Khodayari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3372 6949
Email address
s-khodayari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-19, 1398/03/29
Expected recruitment end date
2019-08-20, 1398/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of Manual Hyperinflation and Postural Drainage on Respiratory Indices in Mechanical Ventilation Patients in Intensive Care Units
Public title
Effect of Hyperinflation and Postural Drainage on Respiratory Indices in Mechanical Ventilation Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
inclusion criteria: Patients older than 18 years and less than 60 years old, positive end expiratory pressure 7.5 cm H2O, endotracheal Intubation, attached to ventilator in volumetric mod for 48 hours, stable hemodynamic status, no chest tube, no chest trauma or: pneumothorax, Embolism, subcutaneous emphysema, burns, skin grafts and chest repair surgery, pregnancy, obesity, No use of cardiac pacemaker
Exclusion criteria:
Exclusion criteria: receiving mucolytic and diluent drugs (bromoxyn, n-acetylcysteine), cramping drugs, starting, discontinuing or changing bronchodilator expansion agents, changes in mechanical ventilation settings, bronchospasm, Increased intracranial pressure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Based on inclusion criteria, 80 patients were randomly assigned to the control group (40 cases) and intervention (40cases). Randomization method: block Randomization; randomization unit: Individual; Random layer: not done; Randomization tool: Random sequence generation software (Excel); How to create random sequence: Using random blocks, each block contains 4 people. Assigning a number from 1 to 6 to each block; random allocation hiding: Due to interventions on Unconscious patients, there is no possibility of hiding random assignments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
dose not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tohid Square, Dr Mirkhani Avenue (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1398.044

Health conditions studied

1

Description of health condition studied
Ventilation disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
O2saturation
Timepoint
Before, 5, 10 and 25 minutes after suctioning
Method of measurement
Pulse Oximeter

2

Description
Respiratory rate
Timepoint
Before, 5, 10 and 25 minutes after suctioning
Method of measurement
Ventilator monitor

3

Description
end expiratory co2
Timepoint
Before, 5, 10 and 25 minutes after suctioning
Method of measurement
Capnograph

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: first day, respiratory parameters ( before routine suctioning and 5, 10 and 25 minutes after Routine suctioning) will be recorded. Then, during the next day before Any time suction, manual dilatation techniques and Postural drainage will be recorded. Then, respiratory parameters (5, 10 and 25 minutes after intervention) will be recorded
Category
Prevention

2

Description
. control group: In the first 24 hours, patients will be suctioned as needed and respiratory parameters (before routine suction and 5, 10 and 25 minutes after routine suctioning) and during the next day, Required suctioning is performed without manual dilatation and postural drainage and respiratory parameters (5, 10 and 25 minutes after suctioning)will be recorded.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Sajad khodayari
Street address
Ayatollah Heidari Street
City
Ilam
Province
Ilam
Postal code
٦٩٣٩١٧٧١٤٣
Phone
+98 84 3333 4500
Email
info@medilam.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Saydeh Fatemeh Waseq Rahim Parvar
Street address
Tavid Square, Dr Mirkhani St. (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6694 1669
Fax
+98 21 6642 7255
Email
vaseghrh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
khatereh seylani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tavid Square, Dr Mirkhani St. (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Nursing Department of Critical Care
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Email
Kh-seylani@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Navab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tavid Square, Dr Mirkhani St. (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Nursing Department of Critical Care
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4412
Email
e-navab@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sajad Khodayari
Position
Master of Science in Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahda Square, Islamic Republic Boulevard, Rababeh Kamali Road, Fourth Floor dosti Building
City
Ilam
Province
Ilam
Postal code
٦٩٣٩١٧٧١٤٣
Phone
+98 84 3333 7204
Email
s-khodayari@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The release plan is still unknown
When the data will become available and for how long
The release plan is still unknown
To whom data/document is available
The release plan is still unknown
Under which criteria data/document could be used
The release plan is still unknown
From where data/document is obtainable
The release plan is still unknown
What processes are involved for a request to access data/document
The release plan is still unknown
Comments
The release plan is still unknown
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