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Investigating The Effect of Adjustment of Peep and Fio2 Based on Arterial Blood Oxygen Pressure on the Care and Treatment Outcomes of Icu Patients

Protocol summary

Study aim
Determining the effect of fio2 and peep adjustment based on arterial blood oxygen pressure on care and treatment outcomes of intensive care unit patients
Design
Clinical trial with control group, block random allocation, pilot study with 30 samples with SPSS software
Settings and conduct
The number of eligible patients in the intensive care unit of Imam Khomeini Hospital in Ahvaz is numbered and each 6 are divided into a block, for example, the first block of all intervention groups, 3 cases of hyperoxemia and 3 cases of hypoxemia. Arterial blood gas sample was recorded before the intervention and with the beginning of the intervention, the peep and fio2 parameters were changed under the supervision of an anesthesiologist for 7 days and every day a blood sample was recorded and placed in the sofa table.
Participants/Inclusion and exclusion criteria
Age group 60-18 years Intubation and connection to the ventilator GCS score of at least 6 No lung disease, lung cancer and Copd No entry: Use of muscle relaxants Post CPR patients Unstable hemodynamics
Intervention groups
15 people in the intervention group, 7 of whom have hypoxemia pao2 <60mmhg and 8 people have hyperoxemia Pao2> 120mmhg, which are randomly divided into 6 blocks.In these two groups in the intervention group, due to arterial blood oxygen pressure, the two parameters of peep and fio2 decrease or increase during 7 days. And according to the sofa criterion, the patient's condition is evaluated. In the control group, 15 patients, including 7 patients with hypoxemia and 8 cases of hyperoxemia, and the parameters of peep and fio2 are routinely adjusted, and the sofa criterion is recorded within 7 days and the patient's condition is checked.
Main outcome variables
Effect on ventilator connection time, Effect on complications due to changes in arterial blood oxygen

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200815048408N1
Registration date: 2020-08-30, 1399/06/09
Registration timing: prospective

Last update: 2020-08-30, 1399/06/09
Update count: 0
Registration date
2020-08-30, 1399/06/09
Registrant information
Name
Malihe Moghaddas ghahfarokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5352 3262
Email address
mgh.gh1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect of Adjustment of Peep and Fio2 Based on Arterial Blood Oxygen Pressure on the Care and Treatment Outcomes of Icu Patients
Public title
"The effect of peep and fio2 modulation on outcome"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 60-18 years Intubation and connection to the ventilator GCS score of at least 6 No lung disease, lung cancer and COPD
Exclusion criteria:
Discharge or death of the patient before the intended time for intervention Use of muscle relaxants Post CPR patients Unstable hemodynamics
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block random allocation method (5 blocks, each block including 6 patients are selected from both intervention and control groups. The number of possible cases from the arrangement of control and intervention patients is determined by MCMCMC that are not duplicates and 6 cases are randomly selected and to each Block is assigned a state, the first block of patients with hyperoxemia, the second block of patients with hypoxemia and also up to block 4 and the last block four to two of each group is placed in the control and intervention group of 8 patients with hyperoxemia and 7 patients with hypoxemia.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is a pilot and the sample size can be changed.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
No. 368, Corner of Bustan 2., Bustan Street
City
Khoramshahr
Province
Khouzestan
Postal code
۶۴۱۷۷۱۷۷۴۳
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
Ir.ajums.rec.1398.713

Health conditions studied

1

Description of health condition studied
Changing the two parameters of peep and fio2 from the ventilator device according to the arterial blood oxygen pressure in the form of hypoxemia and hyperoxemia on the therapeutic outcomes and care of patients admitted to the intensive care unit.
ICD-10 code
T88.8
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified

Primary outcomes

1

Description
Arterial blood oxygen pressure in the form of hypoxemia (Pao2<60mmhg)and hyperoxemia(Pao2>120mmhg).
Timepoint
Before the intervention and during 7 days of intervention
Method of measurement
arterial blood gases

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 15 people in the intervention group, 7 of whom have hypoxemia pao2 <60mmhg and 8 people have hyperoxemia Pao2> 120mmhg, which are randomly divided into 6 blocks.In these two groups in the intervention group, due to arterial blood oxygen pressure, the two parameters of peep and fio2 decrease or increase during 7 days. And according to the sofa criterion, the patient's condition is evaluated.
Category
Treatment - Devices

2

Description
Control group: 15 patients, including 7 patients with hypoxemia and 8 cases of hyperoxemia, and the parameters of peep and fio2 are routinely adjusted, and the sofa criterion is recorded within 7 days and the patient's condition is checked.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Malihe Moghaddas Ghahfarokhi
Street address
No. 368, Corner of Bustan 2., Bustan Ave.
City
Khoramshahr
Province
Khouzestan
Postal code
6417717743
Phone
+98 61 5352 3262
Email
Mgh.gh1990@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badavi
Street address
No.368, Corner of Bustan 2., Bustan Ave
City
Khoramshahr
Province
Khouzestan
Postal code
۶۴۱۷۷۱۷۷۴۳
Phone
+98 61 5352 3262
Email
Mgh.gh1990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Malihe Moghaddas Ghahfarokhi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No. 368, Corner of Bustan 2., Bustan Ave
City
Khoramshahr
Province
Khouzestan
Postal code
6417717743
Phone
+98 61 5352 3262
Email
Mgh.gh1990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Malihe Moghaddas Ghahfarokhi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No. 368, Corner of Bustan 2., Bustan Street
City
Khoramshahr
Province
Khouzestan
Postal code
۶۴۱۷۷۱۷۷۴۳
Phone
+98 61 5352 3262
Fax
Email
mgh.gh1990@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Malihe Moghaddas Ghahfarokhi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No. 368, Corner of Bustan 2., Bustan Ave
City
Khoramshahr
Province
Khouzestan
Postal code
۶۴۱۷۷۱۷۷۴۳
Phone
+98 61 5352 3262
Email
Mgh.gh1990@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Reports on blood test, sex, age, date of hospitalization, length of hospital stay, underlying disease, ventilator parameters
When the data will become available and for how long
"Access period starts 6 months after the results are published"
To whom data/document is available
Employees in universities and researchers
Under which criteria data/document could be used
Help improve the condition of patients admitted to the intensive care unit, help reduce costs, use as a resource for other research.
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Have basic scientific information about ventilators
Comments
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