The purpose of the study: Effect of Prone Position on Oxygenation in patients with acute respiratory failure under mechanical ventilation.
Design:Experimental, Before and After intervention.
The Study population: Patients with acute respiratory failure under mechanical ventilation
Target sample size: 54 patients
Blinding: Not blinding
Randomization: Not randomized
Inclusion criteria: lack of chronic lung disease; Non-Cardiac Origin Pulmonary Disease; no evidence of left atrial hypertension.
Exclusion criteria: adverse change in the number heart rate; an adverse change in respiratory rate; adverse chance in blood pressure; reducing the amount of oxygen in arterial blood; need to change the ventilation mode; the incidence of serious cardiac arrhythmia including ventricular tachycardia.
Intervention: Put the patient in the prone position.
Intervention time: Three days for each patient.
The primary outcome: Arterial blood oxygen saturation.
The secondary outcomes: The pressure of arterial oxygen to the percentage of inspired oxygen.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052534130N1
Registration date:2017-06-29, 1396/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-29, 1396/04/08
Registrant information
Name
Ziba Hajivand Solymani
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 2535
Email address
hajivand.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2017-05-26, 1396/03/05
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Prone Position on Oxygenation in patient with Acute Respiratory failure under Mechanical Ventilation
Public title
The effect of Prone Position on improving Patients with Respiratory failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: lack of chronic lung disease; non-cardiac origin pulmonary disease; no evidence of left atrial hypertension.
Exclusion criteria: adverse change in the number heart rate; an adverse change in respiratory rate; adverse chance in blood pressure; reducing the amount of oxygen in arterial blood; need to change the ventilation mode; the incidence of serious cardiac arrhythmia including ventricular tachycardia.
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:
54
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz University of Medical Sciences, Golestan Alley, Esfand St., Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Approval date
2017-05-05, 1396/02/15
Ethics committee reference number
IR.AJUMS.REC.1396.96
Health conditions studied
1
Description of health condition studied
Acute respiratory failure
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
Arterial Blood Oxygen Saturation
Timepoint
30 minutes after Supine Position and 30 minutes after Prone Position
Method of measurement
Arterial Blood Gases
Secondary outcomes
1
Description
the pressures of arterial oxygen to the percentage share of inspired oxygen
Timepoint
30 minute after supine position and 30 minute after prone position
Method of measurement
Arterial blood gases
Intervention groups
1
Description
prone position
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of Golestan Ahvaz
Full name of responsible person
Ziba Hajivand Solymani
Street address
Golestan Hospital, Golestan Alley, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmal Zadeh
Street address
Vice chancellor for research, Ahvaz University of Medical Sciences, Golestan Alley, Esfand St., Ahvaz, Khuzestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ziba Hajivand Solymani
Position
Nursing Student
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, Golestan Alley, Esfand St., Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8070
Fax
Email
hajivand.z@ajums.ac.ir; hajivand.h.gh@gmaile.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
PhD Nursing
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, Golestan Alley, Esfand St., Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8070
Fax
Email
jahanisimin50@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ziba Hajivand Solymani
Position
Nursing Student
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, Golestan Alley, Esfand St., Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8070
Fax
Email
hajivand.z@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)