Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000638639
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
17/06/2014
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perfusion index as a predictor for optimum positive end -expiratory pressure in Acute Respiratory Distress Syndrome patients management
Scientific title
Perfusion index as a predictor for optimum positive end-expiratory pressure(PEEP) in acute respiratory distress syndrome(ARDS) patients management
Secondary ID [1] 284547 0
Nil
Universal Trial Number (UTN)
U1111-1156-3719
Trial acronym
Pip ops
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We will study the relation between perfusion index and optimum PEEP in Acute respiratory distress syndrome(ARDS) patients 291811 0
Condition category
Condition code
Anaesthesiology 292173 292173 0 0
Anaesthetics
Respiratory 292212 292212 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will titrate the PEEP level from baseline(5cm.H2O) by increments of 2cm.H2O for 30 minutes for each PEEP level till reaching the value of optimum PEEP that corresponds to best oxygenation(Pao2-sao2 and hypoxic index ) and correlates it with the perfusion index changes in ARDS patients.
Intervention code [1] 289350 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292054 0
Optimum PEEP in ARDS patients. tools used include hemodynamic parameters(MAP-C.V.P.) ,oxygenation parameters(Pao2-sao2-hypoxic index{pao2/fio2} )-static compliance- dead space to tidal volue ratio(Vd/Vt).
Timepoint [1] 292054 0
6 hours after confirmation of ARDS diagnosis
Secondary outcome [1] 308087 0
Nil
Timepoint [1] 308087 0
Nil

Eligibility
Key inclusion criteria
ARDS patients due to pulmonary causes (eg severe pneumonia).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Extra pulmonary causes of ARDS, pneumothorax, coagulapathy CHF , cardiogenic pulmonary edema, hemodynamics instability.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data are presented as median , range values . paired T. test will be used. Sample size , according to the survey system software.we assumed confidence level of 95% at appropriate confidence interval to detect 15% difference in perfusion index ,the sample size of total 20 cases was calculated(www.surveysystem.com).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
5/05/2014
Date of last participant enrolment
Anticipated
5/06/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 6031 0
Egypt
State/province [1] 6031 0
Qena
Country [2] 26361 0
Egypt
State/province [2] 26361 0
Mansoura

Funding & Sponsors
Funding source category [1] 289173 0
University
Name [1] 289173 0
South valley university
Country [1] 289173 0
Egypt
Primary sponsor type
University
Name
South valley university
Address
Qena Egypt postal code 85823
Country
Egypt
Secondary sponsor category [1] 287842 0
None
Name [1] 287842 0
Nil
Address [1] 287842 0
Nil
Country [1] 287842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290950 0
Qena faculty of medicine ethics commitee
Ethics committee address [1] 290950 0
Ethics committee country [1] 290950 0
Egypt
Date submitted for ethics approval [1] 290950 0
05/05/2014
Approval date [1] 290950 0
05/05/2014
Ethics approval number [1] 290950 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48126 0
Dr Hatem saber Mohamed-south valley university.
Address 48126 0
South valley university- Qena faculty of medicine-postal code 85823-Qena.
Country 48126 0
Egypt
Phone 48126 0
+201005257062
Fax 48126 0
Email 48126 0
[email protected]
Contact person for public queries
Name 48127 0
Salah mostafa asida-south valley university.
Address 48127 0
South valley university- Qena faculty of medicine-postal code 85823-Qena.
Country 48127 0
Egypt
Phone 48127 0
+201005262075
Fax 48127 0
Email 48127 0
[email protected]
Contact person for scientific queries
Name 48128 0
Salah asida-south valley university.
Address 48128 0
South valley university- Qena faculty of medicine-postal code 85823-Qena.
Country 48128 0
Egypt
Phone 48128 0
+201005262075
Fax 48128 0
Email 48128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.