Determination of the effect of lung therapy on arterial blood parameters for patients under mechanical ventilation
Design
clinical trial of crossover، has two groups, with cross - groups, randomized
Settings and conduct
fourty ICU patients will be entered into the study. patients will be randomly allocated to two groups. the first group will be riecived planned lung physiotherapy and routine lung physiotherapy in first day, then after 24 hour wash out, they riecived only routine physiotherapy in second day. second group will be riecived only routine lung physiotherapy in first day, then after 24 hour wash out, they riecived planned and routine lung physiotherapy. arterial blood gas parameters will be analized before, half an hour later and 8 hour later lung physiotherapy in both days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients from 18 to 60 years, have arterial blood line, mechanical ventilated patients for 5 - 3 days.
Exclusion criteria: patients with broken ribs, acute bleeding, high brain pressure, spinal cord surgery
Intervention groups
The intervention group includes patients who have received the planned lung physiotherapy and routine lung physiotherapy. The control group includes patients who receive only routine lung physiotherapy.
Main outcome variables
- PaO2
- PaCO2
- SaO2
- PH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181112041630N1
Registration date:2019-04-25, 1398/02/05
Registration timing:retrospective
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
Fahime Soheili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3628 1557
Email address
f.soheili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of planned lung physiotherapy on arterial blood gas parameters in patients undergoing mechanical ventilation
Public title
The effect of lung physiotherapy on arterial blood gas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing mechanical ventilation for 3-5 days
Exclusion criteria:
the patients with rub fracture
acute bleeding
subcutaneous emphysema
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling from patients with inclusion criteria was performed using random allocation software. after selecting the study sample, they were assigned to two groups using the random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
This study is a randomized clinical trial of single - group crossover.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee in biomedical research
Street address
shahid sadoughi
City
yazd
Province
Yazd
Postal code
8914937598
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.SSU.REC.1397.013
Health conditions studied
1
Description of health condition studied
Diseases of the respiratory system
ICD-10 code
Z40-Z54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
Arterial blood gas
Timepoint
Before, half an hour and eight hour after the intervention
Method of measurement
Arterial Blood Gas analizer machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will be riecived planned lung physiotherapy involves the positional dranage, chest percution, chest vibration with the vibrator and the coughing induction and suctioning the airway secretions for 20 minutes.
Category
Rehabilitation
2
Description
Control group: They will be ricieved routine lung physiotherapy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid sadoughi and seyedoshohada hospital in yazd
Full name of responsible person
fahime soheili
Street address
modares
City
yazd
Province
Yazd
Postal code
8914937598
Phone
+98 35 3628 1557
Email
fahime.soheili@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
fahime soheili
Street address
shahid sadoughi
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Email
f.soheili@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Private
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
Yazd University of Medical Sciences
Full name of responsible person
Fahime Soheili
Position
A master's degree of intensive care nursing student
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
modares
City
yazd
Province
Yazd
Postal code
8914937598
Phone
+98 35 3628 1557
Email
fahime.soheili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
fahime soheili
Position
A master's degree of intensive care nursing student
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
modares
City
yazd
Province
Yazd
Postal code
8914937598
Phone
+98 35 3628 1557
Email
fahime.soheili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
fahime soheili
Position
A master's degree of intensive care nursing student
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
modares
City
yazd
Province
Yazd
Postal code
8914937598
Phone
+98 35 3628 1557
Email
fahime.soheili@yahoo.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