Comparison of plus pressuer variation and plus oximetry oscillation in the prediction of the response of fluid therapy in traumatic patients connectedto ventilators admitted in intensive care uint
Comparison of pulse pressure and oximeter pulse fluctuations in predicting fluid therapy response in ventilator-connected patients admitted to the intensive care unit
Design
The sample size for the study is to examine the area under the ROC curve:
Using Medcalc software and considering the area under the curve 0.80 as the optimal area under the curve, the type I error was 0.05 and the power of 90% (type II error 0.10) of the sample size in each Responder and Non responder group was 17.
Finally, in order to increase the power to 95% of the sample size, each group was considered 20 people and 40 people in total.Sampling will be done through available sampling and 40 patients will be enrolled according to inclusion criteria.
Settings and conduct
This is a clinical trial study of diagnostic methods. The study population will be trauma patients undergoing mechanical ventilation admitted to the intensive care unit of Bahonar Hospital.
Participants/Inclusion and exclusion criteria
Ventilator Connected Patients With control Breathing Admitted to intensive Care Ages 18 to 80 years old. And they have no heart problems. And they are not pregnant.
Intervention groups
The number of people included in this study is 40 people. After selecting and adjusting the ventilator for the patient, treatment with 250 cc ringer begins. Due to the increase in MAP, it is divided into two groups: responders and non-responders to fluid therapy. Then PPV changes in pulse oximetry and arterline waves are investigated.
Main outcome variables
1-Pulse pressure and oximeter pulse fluctuations vary with age.
2. Pulse pressure and oximeter pulse oscillations vary by sex.
3. Pulse pressure and oximeter pulse oscillations vary by weight.
4. Pulse pressure and oximeter pulse fluctuations vary in height
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190720044284N1
Registration date:2021-01-12, 1399/10/23
Registration timing:prospective
Last update:2021-01-12, 1399/10/23
Update count:0
Registration date
2021-01-12, 1399/10/23
Registrant information
Name
yousef Arefi Maskoni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3226 5439
Email address
y.arefi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of plus pressuer variation and plus oximetry oscillation in the prediction of the response of fluid therapy in traumatic patients connectedto ventilators admitted in intensive care uint
Public title
comparison of plus pressuer variation and plus oximetry oscillation in the prediction of the response of fluid therapy in traumatic patients connectedto ventilators admitted in intensive care uint
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized in intensive care units
Ages 18 to 80 years
Breathing control with a tidal volume of 8 to 10 cc / kg
Lack of advanced heart and respiratory disease
Exclusion criteria:
Dissatisfaction with patient companions
Spontaneous breathing
Under 18 and over 80 years
Being pregnant
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients or their patient's companions are not aware of other patients and interventions performed.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kerman University of Medical Sciences
Street address
Kerman, Qarni St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2020-11-23, 1399/09/03
Ethics committee reference number
IR.KMU.REC.1399.468
Health conditions studied
1
Description of health condition studied
comparison of plus pressuer variation and variation in the amplitud of the plus oximetry plethysmographic waveform( ◇POP) in the prediction of the response of fluid therapy in traumatic patients connected to ventilators admitted in intensive care uint
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pulse pressure variation
Timepoint
At the beginning of the intervention and 45 minutes after the intervention
Method of measurement
The difference between the maximum pulse pressure and the minimum pulse pressure is divided by half the sum of the maximum pulse pressure and the minimum pulse pressure and the result will be multiplied by 100. (Pulse pressure is the difference between systolic and diastolic blood pressure from one heartbeat to the next. Pulse oximetry will be recorded on the arterial pressure monitoring chart.
Secondary outcomes
empty
Intervention groups
1
Description
Category
empty
2
Description
Intervention group: For all trauma patients admitted to the intensive care unit who are under mechanical ventilation, before the start of fluid therapy (according to the protocol) pulse pressure fluctuations according to the above formula and pulse oximetry and arterial pressure of the patient MAP, SBP, PR, RR will be measured. Treatment is started for the patient (250 cc of crystalloid serum) then after 45 minutes the patient's pulse pressure and pulse oximetry fluctuations will be measured again and patients according to the response to fluid therapy into two groups Responder (increase in MAP more than 15% Non responder is divided and ppv changes are measured based on atraline waves and pulse oximetry. The patient's condition will also be recorded in response to fluid therapy.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital, Qarni St. ,Kerman
Full name of responsible person
Mehdi Ahmadinejad
Street address
Shahid Bahonar Hospital, Qarni St. ,Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mahmadinejad @kmu.ac.ir
Web page address
http://bh.kmu.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinjad
Street address
Kerman, Qarni St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Yosef.am@gmall.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Hospital, Qarni St. ,Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mahmadinejad@kmu.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yousef Arefi Maskoni
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Hospital, Qarni St. ,Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Yosef.am@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yousef Arefi Maskoni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Hospital,Qarni St. ,Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Yosef.am67@gmall.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not 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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available