Evaluation of Ultrasonographic lung Recruitibility with Two Types of Positive End Expiratory Pressure Selection in Moderate to Severe Acute Respiratory Distress Syndrome
Determination of ultrasonographic lung recruitibility with two type of positive end expiratory pressure (PEEP) titration in Acute respiratory distress syndrome (ARDS)
Design
A quasi-experimental study with "before and after" design
with a sample size of 15 patients and without randomization
Settings and conduct
This study will be done in Mashhad University of medical sciences, Emam Reza hospital and in intensive care unit.
Diagnosis and selection of patients with acute respiratory distress syndrome and also other stages of the study including lung ultrasonography will be done by the fellowship of critical care medicine.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Moderate to severe ARDS patients (based on Berlin criteria ), older than18 and under invasive mechanical ventilation
Exclusion criteria: Known heart failure or acute ischemic heart disease, chronic respiratory disease, increased intracranial pressure, morbid obesity
Intervention groups
In this study,15 patients with moderate to severe ARDS who need invasive mechanical ventilation will be selected.
Initially, patients will be ventilated according to ARDS net protocol and positive end expiratory pressure (PEEP) selection will be based on the lowest recommended level in the "low PEEP table", then lung aeration will be assessed by ultrasonography.After 30 minutes, PEEP level will be adjusted according to EXPRESS trial and assessment of lung aeration by ultrasonography will be repeated. Both types of PEEP selection will be applied to each patient and in fact, control and intervention group are the same.
Main outcome variables
lung recruitment(Reaeration) according to sonographic criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150427021981N1
Registration date:2018-04-04, 1397/01/15
Registration timing:registered_while_recruiting
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38023763
Email address
bagheria@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ultrasonographic lung Recruitibility with Two Types of Positive End Expiratory Pressure Selection in Moderate to Severe Acute Respiratory Distress Syndrome
Public title
Ultrasonographic ٍEvaluation of lung Recruitability in Acute Respiratory Distress Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Moderate to Severe Acute Respiratory Distress Syndrome and under invasive mechanical ventilation
Exclusion criteria:
Younger than 18 year
Less than 24 h or more than 96 h after the onset of the disease.
Unstable hemodynamic
Contraindication for using of high PEEP
Known heart failure
Acute ischemic heart disease or uncontrolled arrythmia
Chronic lung disease
BMI>40
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is quasi-experimental with "before-after" design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of mashhad university of medical sciences
Street address
ghoreishi building,daneshgah street,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.MUMS.fm.REC.1396.488
Health conditions studied
1
Description of health condition studied
Acute Respiratory Distress Syndrome
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome
Primary outcomes
1
Description
lung recruitability (Reaeration) with two type of positive end expiratory pressure selection
Timepoint
Initial measurement of lung recruitment (Reaeration) with a low level of positive end expiratory pressure (low PEEP table) and after 30 minutes with a high positive end expiratory pressure level (Express trial)
Method of measurement
By lung ultrasonography with 2.5 to 5 megahertz curve probe
Secondary outcomes
1
Description
Oxygenation state
Timepoint
Five minutes after positive end expiratory pressure (PEEP) change
Method of measurement
Dividing the arterial oxygen pressure to the fraction of inspired oxygen (Po2/Fio2 ratio)
Intervention groups
1
Description
Intervention and control group: Use of positive end expiratory pressure according to"low PEEP table" in ARDS net protocol during mechanical ventilation (control group) and then (after 30 minutes), Use of positive end expiratory pressure according to recommended level in "Express trial" in the same patient (intervention group)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital,Intensive care unit
Full name of responsible person
Ahmad bagheri moghaddam
Street address
Emam reza hospital, Emam reza square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
bagheriA@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad bagheri moghaddam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Critical care
Street address
No.187, yasaman 6 Ave, sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9186684736
Phone
+98 51 3760 6328
Email
bagheriA@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad bagheri moghaddam
Position
Assitant professor
Latest degree
Subspecialist
Other areas of specialty/work
critical care
Street address
No.187,Yasaman 6 Ave, Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9186684736
Phone
+98 51 3760 6328
Email
bagheriA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad bagheri moghaddam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
critical care
Street address
No.187, Yasman 6 Ave, Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9186684736
Phone
+98 51 3760 6328
Email
bagheriA@mums.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
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
Undecided - It is not yet known if there will be 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