Protocol summary

Study aim
The effect of manual precision and mechanical vibration on pulmonary parameters of patients undergoing mechanical ventilation in intensive care units
Design
A randomized crossover clinical trial
Settings and conduct
For each patient, there are 90 minutes intervals between manual precussion and mechanical vibration which is done by researcher. To perform a manual precision, the wrist strikes the right wrist, which is cup-shaped and equal in strength from the height of ten centimeters to the back and front of the patient's chest. The chest is divided into four segments, percussion done for each with a thirty-second . These beats are performed at speeds of 4 times per second for 4 minutes at the time of Inhale and exhale To vibrate , a constant frequency of 2 Hz is used, and is performed by the researcher for 1 to one and a half minutes during the patient's breathing during exhalation. The shaking is done by placing the vibrating device on the back and front of the chest. In this intervention, the chest is divided into four upper and lower right and left sections, each of which is vibrated by five vibrations during exhalation.
Participants/Inclusion and exclusion criteria
Age over 18 years   Being connected to a mechanical ventilator   Complete cardiopulmonary monitoring   Hemodynamic stability in the last 6 hours according to anesthesiologist Absence of spinal cord injuries No lung disease and no pneumothorax, hemothorax and rib fracture   Recurrent volume of gastric discharge less than 100 ml before intervention
Intervention groups
Group A is the group which first receive manual percussion and after the wash out period mechanical vibration is performed on them Group B is the group that is first mechanical vibration performed after the washout period recieve manual percussion.
Main outcome variables
Pulmonary compliance Airway Resistance  Arterial blood oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100921004787N6
Registration date: 2020-02-19, 1398/11/30
Registration timing: prospective

Last update: 2020-02-19, 1398/11/30
Update count: 0
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
Tahereh Khaleghdoost Mohammadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5058
Email address
khaleghdoost@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effect of manual percussion and mechanical vibration on respiratory indexes in mechanically ventilated patients
Public title
Survey effect of manual percussion and mechanical vibration on respiratory indexes in mechanically ventilated patients in Rasht Poursina hospital critical care units 2019- 2020
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Connected to mechanical ventilation Complete cardiopulmonary monitoring Hemodynamic stability in the last 6 hours according to anesthesiologist Absence of spinal cord injuries No pulmonary disease and no pneumothorax, hemothorax and rib fracture Recurrent volume of gastric lavage less than 100 ml before intervention
Exclusion criteria:
Hemodynamic parameters instability Increased intracranial pressure The need for emergency suctioning during the intervention Changes in ventilator device settings and modes during the study Patient leaving the ward to perform paraclinical procedures and withdraw from monitoring
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Specimens are assigned randomly to quadruple blocks in order to select the sequence of intervention in groups A and B, which will be sequenced using" Random block " software. The proprietary Randomized Allocation is kept in a sealed package with the ward supervisor. And before starting the intervention will open. Based on the daily and inpatient referrals in the section according to the sequence of samples will be divided into groups A and B. Group A is the group which first receive manual percussion and after the wash out period mechanical vibration is performed on them and Group B is the group that is first mechanical vibration performed after the washout period recieve manual percussion.
Blinding (investigator's opinion)
Single blinded
Blinding description
participant. They do not know the order of the interventions
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.GUMS.REC.1398.468

Health conditions studied

1

Description of health condition studied
Chest physiotherapy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pulmonary compliance
Timepoint
Before intervention and 1, 5, 15, 30 minutes after intervention in each group
Method of measurement
View on ventilator screen

2

Description
Airway resistance
Timepoint
Before intervention and 1, 5, 15, 30 minutes after intervention in each group
Method of measurement
View on ventilator screen

3

Description
Percentage of arterial blood oxygen saturation
Timepoint
Before intervention and 1, 5, 15, 30 minutes after intervention in each group
Method of measurement
From the monitoring screen connected to the patient

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: or group A: the group that first received manual percussion and after wash out period mechnical vibration perform on them .one hour after suction and before the intervention started ,the indices like pulmonary compliance and airway resistance seen on the ventilator screen is recorded as well as the percentage of arterial oxygen saturation from the monitor next to the patient's bed. Indicators are recorded immediately after each intervention, and at 1, 5, 15 and 30 minutes after each intervention.
Category
Prevention

2

Description
Intervention group: the group that first received mechanical vibration and after wash out period manual percussion perform on them .one hour after suction and before intervention started ,the indices like pulmonary compliance and airway resistance seen on the ventilator screen is recorded as well as the percentage of arterial oxygen saturation from the monitor next to the patient's bed. Indicators are recorded immediately after each intervention, and at 1, 5, 15 and 30 minutes after each intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Medical and Educational Hospital
Full name of responsible person
Nasim Rasoulnia
Street address
Poursina Crossroads Rasht Poursina Educational Hospital
City
Rasht
Province
Guilan
Postal code
1319441937
Phone
+98 13 3332 2444
Fax
Email
poursina_pr@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohamad reza Naghipoor
Street address
Namjoo Street Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 6394
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Guilan university of medical science
Proportion provided by this source
1
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
Rasht University of Medical Sciences
Full name of responsible person
Nasim Rasoulnis
Position
Student of Master science of medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 3302
Email
nasim.msn2014@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
science committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 3202
Email
khaleghdoost@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
science commmittee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 3202
Email
khaleghdoost@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is 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
No - There is not 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
Once the data collection is complete, the decision will be made
When the data will become available and for how long
Starting access after printing the article
To whom data/document is available
Everyone who reads the article
Under which criteria data/document could be used
Everyone wants to refer to the article
From where data/document is obtainable
Article Printers Magazine Website
What processes are involved for a request to access data/document
Additional information can be requested by email
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