Comparison of the effect of three passive respiratory exercises (percussion, vibration and manual hyperinflation) methods on cardiopulmonary functions of patient under mechanical ventilation in critical care unit of Besat theraputic and educational center, Hamadan University of Medical Sciences
Objectives: To investigate the effect of passive respiratory exercises on cardiopulmonary function in patient undergoing mechanical ventilation.
Design: A crossover randomized clinical trial.
Setting and conduct: The patients in ICU will be enrolled in the study if they fulfill the eligibility criteria
Participants including major eligibility criteria: The patients with the following criteria will be included: (a) having intra-tracheal tube or tracheostomy; (b) using ventilator; (c) age of 18 or greater; (d) stable hemodynamic status during last six hours. The patients with any one of the following criteria will be excluded from the study: (a) using dopamine, dobutamine, or nitroglycerine; (b) spinal cord injury; (c) hemorrhage in respiratory system; (d) history of myocardial infarction; (e) pneumothorax or rib fracture; (f) presence of arrhythmia in monitor; (g) respiratory distress such as cyanosis; (h) intra cranial pressure.
Intervention: Three different intervention will be assessed and compared including: (a) vibration of the back of thorax using vibrator device once for two minutes; (b) percussion of the back of thorax knocking gentling one for four minutes; (c) manual hyperinflation using ambo bag to inspire via tracheal tube or thoracotomy, stop for three seconds then expire rapidly relaxing ambo bag.
Main outcome measures: The outcome of interest is cardiopulmonary function which will be assessed as follows: (a) systolic and diastolic blood pressure per mmHg using monitor device; (b) heart beat per minute using monitor device; (c) arterial oxygen saturation per percent using monitor device; (d) assessing pulmonary compliance per mL/mBar using monitor device; (e) airway resistance per mBar/mL/s using monitor device.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203169014N8
Registration date:2012-07-09, 1391/04/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-09, 1391/04/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of three passive respiratory exercises (percussion, vibration and manual hyperinflation) methods on cardiopulmonary functions of patient under mechanical ventilation in critical care unit of Besat theraputic and educational center, Hamadan University of Medical Sciences
Public title
The effect of passive respiratory exercises on cardiopulmonary function in patient undergoing mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
The patients in ICU will be enrolled in the study if they have the following criteria: (a) having intra-tracheal tube or tracheostomy; (b) using ventilator; (c) age of 18 or greater; (d) stable hemodynamic status during last six hours. The patients with any one of the following criteria will be excluded from the study: (a) using dopamine, dobutamine, or nitroglycerine; (b) spinal cord injury; (c) hemorrhage in respiratory system; (d) history of myocardial infarction; (e) pneumothorax or rib fracture; (f) presence of arrhythmia in monitor; (g) respiratory distress such as cyanosis; (h) intra cranial pressure.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review board
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
D/P/16/35/9/1283
Health conditions studied
1
Description of health condition studied
Patient undergoing mechanical ventilation
ICD-10 code
J95
ICD-10 code description
Postprocedural respiratory disorders, not elsewhere classified
Primary outcomes
1
Description
The outcome of interest is cardiopulmonary function which will be assessed as follows: (a) systolic and diastolic blood pressure per mmHg using monitor device; (b) heart beat per minute using monitor device; (c) arterial oxygen saturation per percent using monitor device; (d) assessing pulmonary compliance per mL/mBar using monitor device; (e) airway resistance per mBar/mL/s using monitor device.
Timepoint
5 min
Method of measurement
Monitor device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Vibration of the back of thorax using vibrator device once for two minutes.
Category
Treatment - Devices
2
Description
Intervention 2: Percussion of the back of thorax knocking gentling one for four minutes.
Category
Treatment - Devices
3
Description
Intervention 3: Manual hyperinflation using ambo bag to inspire via tracheal tube or thoracotomy, stop for three seconds then expire rapidly relaxing ambo bag.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Dr Ali Beikmoradi
Street address
Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
از محل يك درصد بودجه طرحهاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Internal Medicine and Surgery
Full name of responsible person
Dr Ali Beikmoradi
Position
PhD
Other areas of specialty/work
Street address
Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
00
Fax
Email
bikmoradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)