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The comparison of the incidence of atelectasis, pleural effusion and pneumonia in patients without ALI-ARDS with two methods of ventilation, normal ventilation and ventilation with open lung concept

Protocol summary

Summary
The aim of study was to compare two methods of ventilation, normal ventilation and ventilation with open lung concept, among patients without ALI-ARDS regarding the incidence of atelectasis, pleural effusion and pneumonia. Forty two intubated patients in Sina hospital ICU ward, who were considered to have mechanically ventilation for at least one week, were allocated into 2 groups. Control group were ventilated with the below setting: PS:5-10, FIO2:50%, PEEP=5cmH2O, TV=6cc/kg, mode: SIMV. Intervention group were ventilated with below setting: PS: 5-10, FIO2:50%, PEEP=8cmH2O, TV=6cc/kg, mode: SIMV. In addition, intervention group were ventilated with APRV mode 10 minutes every 4 hours at pressure of 40 cmH2o during the study. CBC, SOFA, compliance and airway resistance were monitored daily in all patients. CRP was evaluated 3 times and cardiac monitoring 2 times during the study. Pulmonary CT scan were done at the start and the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122211840N1
Registration date: 2013-02-08, 1391/11/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-08, 1391/11/20
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 5936
Email address
heydari_f@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-04-04, 1392/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the incidence of atelectasis, pleural effusion and pneumonia in patients without ALI-ARDS with two methods of ventilation, normal ventilation and ventilation with open lung concept
Public title
The comparison of the incidence of atelectasis, pleural effusion and pneumonia in patients without ALI-ARDS with two methods of ventilation, normal ventilation and ventilation with open lung concept
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) Pao2/FIO2>350; 2) age 20-65 yrs. Exclusion criteria: 1) pneumonia; 2) Heart failure; 3) History of lung disease (asthma, COPD, Bronchectasia); 4) ALI; 5) ARDS; 6) patient or families refusal.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
School of Medicine, north side of Tehran University, Poursina Street
City
Tehran
Postal code
1417613151
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
17969/210/د/91

Health conditions studied

1

Description of health condition studied
Atelectasis
ICD-10 code
J98
ICD-10 code description
Other respiratory disorders

Primary outcomes

1

Description
Pneumonia
Timepoint
at the begining and 7 days later
Method of measurement
Symptoms of pulmonary critical-CT Scan - leukocytosis - culture of respiratory secretions

Secondary outcomes

1

Description
Hemodynamics
Timepoint
Every 4 hours for 7 days
Method of measurement
Heart Monitor, Blood Pressure Meter, Thermometer, Pulse oximetry

Intervention groups

1

Description
Control group were ventilated with the below setting: PS:5-10, FIO2:50%, PEEP=5cmH2O, TV=6cc/kg, mode: SIMV
Category
Prevention

2

Description
Intervention group were ventilated with below setting: PS: 5-10, FIO2:50%, PEEP=8cmH2O, TV=6cc/kg, mode: SIMV.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital ICU
Full name of responsible person
Dr Fatemeh Heidari, Assistant Anesthesiology and Intensive Care
Street address
Sina hospital, Imam Khomeini St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Poursina Street - north side of Tehran University - School of Medicine
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
Dr Arezo Ahmadi
Position
Assistant Professor of Anesthesia and Intensive Care
Other areas of specialty/work
Street address
Sin Hospital, Imam Khomeini Avenue
City
Tehran
Postal code
4691111367
Phone
+98 21 2290 1137
Fax
Email
areezo24@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Atabak Najafi
Position
Associate Professor of Anesthesia and Intensive Care
Other areas of specialty/work
Street address
Imam Khomeini
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
nadjafiha@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
Dr Fatemeh Heidari
Position
Assistant Anesthesiology and Intensive Care
Other areas of specialty/work
Street address
Sina hospital, Imam Khomeini St
City
Tehran
Postal code
4691111367
Phone
+98 21 6646 4924
Fax
Email
heydari_f@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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