Comparison of Syncronized Intermittent Mandatory ventilation and Pressure Support Ventilation in oxygenation and lung mechanics in critically ill patients
Pneumonia and Atelectasis are common cause of mortality and morbidity in ICU patients undergo mechanical ventilation and they cause prolongation in ICU stay more than 5 days. In this study, we want to present an acceptable and effective mode of ventilation among PSV and SIMV in order to prevent organ damage which prolong ICU stay and cause mortality. In a randomized clinical trial, 40 patients who were hospitalized in ICU ward at Sina hospital in 2014 and required to mechanical ventilation were randomly assigned to receive SIMV mode(n = 20) or PSV mode (n = 20). Hemodynamic, metabolic, and respiratory indices were assessed within 6 days of ventilation setting.Patients died before 48hr post ICU admission, with a history of pulmonary, hepatic, renal cardiac or brain disease and hypertension, patient discontent and who without spontaneous respiration were excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102215109N1
Registration date:2015-08-16, 1394/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-16, 1394/05/25
Registrant information
Name
Afarin Zamani
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 216643044
Email address
a_zamani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Syncronized Intermittent Mandatory ventilation and Pressure Support Ventilation in oxygenation and lung mechanics in critically ill patients
Public title
Comparison of oxygenation and lung mechanics between two types of mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: need to mechanical ventilation more than 1 week;
age between 20-50 years old;
normal pulmonary mechanic(C>50 and R<10)
Exclusion criteria:patient who death before 48 hours of admission in ICU;
History of asthma, COPD, bronchectasis, and other pulmonary disease;
history of liver, brain, heart and kidney disease;
inadequate spontaneous breathing;
refuse of patient
Age
From 20 years old to 50 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods Ave., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-08-25, 1393/06/03
Ethics committee reference number
93/S/1113/130
Health conditions studied
1
Description of health condition studied
Respiratory failure that needs mechanical ventilation
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified
Primary outcomes
1
Description
Given Oxygen volume
Timepoint
every day for six days
Method of measurement
Manumeter
2
Description
Compliance
Timepoint
every day for six days
Method of measurement
Spirometer
3
Description
pulmonery end expiratory pressure
Timepoint
every day for six days
Method of measurement
Ventilator
4
Description
100 mili second pressure
Timepoint
every day for six days
Method of measurement
pressure gauge
Secondary outcomes
1
Description
pneumonia
Timepoint
every 3 days for six days
Method of measurement
Symptoms and lung CT scan
2
Description
Symptoms and imaging of acute respiratory distress syndrome
Timepoint
every 3 days for six days
Method of measurement
History taking and lung CT scan
3
Description
Symptoms of Ventilator related injury
Timepoint
every 3 days for six days
Method of measurement
History taking
4
Description
cardiac output
Timepoint
every day for six days
Method of measurement
Echocardiography
5
Description
asynchrony
Timepoint
every day for six days
Method of measurement
Symptoms
Intervention groups
1
Description
Synchronized intermittent mechanical ventilation
Category
Treatment - Other
2
Description
pressure support ventilation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Atabak Najafi
Street address
Sina hospital, Hasan Abad Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Afarin Zamani
Position
Resident of Anesthesiology and Critical Care
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad square
City
Tehran
Postal code
Phone
+98 21 6604 3044
Fax
Email
mitra_az63@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atabak Najafi
Position
Assossiate proffesor
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad sq.
City
Tehran
Postal code
Phone
+98 216312530
Fax
Email
nadjafia@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afarin Zamani
Position
Resident of Anesthesiology and Critical care
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad sq.
City
Tehran
Postal code
Phone
+98 21 6604 3044
Fax
Email
mitra_az63@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)