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Comparison of the effect of respiratory physiotherapy and peep changes on the results of capnography in patients with ventilator associated pnemonia.

Protocol summary

Study aim
The purpose of our application is to use respiratory physiotherapy instead of PEEP, to reduce the complications of using PEEP. General purpose: Determining the Comparative Effect of Respiratory Physiotherapy and PEEP Changes in Patients with VAP, Based on Expiratory CO2 Exits. Determine and compare the amount of expiratory CO2 removal after respiratory physiotherapy, and the effect of PEEP changes in patients with VAP.
Design
Clinical practice has two groups of study, With parallel groups، Without blinding, Sampling is easy and accessible with random allocation.
Settings and conduct
Place of study: ICU of Hasheminejad Hospital in Mashhad. How to do the study: In a group that has PEEP five، We put PEEP ten for thirty minutes. And then we record the results of the capnography. In another group that has PEEP five, We perform three types of respiratory physiotherapy for 15 minutes.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients aged 18 to 80 years. The patient has a tracheal tube and is connected to a ventilator. Patient with pneumonia associated ventilator، with positive chip culture. The patient is under the ventilator and has the parameter PEEP. Conditions of failure to enter: A patient with systolic blood pressure of less than 90 mmHg. Patient with rib fractures and chest tube. Patient with high ICP Symptoms. Patient with fracture of cervical and lumbar spine and preservation of immobility. Patient with abdominal and chest surgeries.
Intervention groups
Samples are divided into two groups. We increase PEEP in one group, and in the other group، we perform respiratory physiotherapy. Compare the results the capnography.
Main outcome variables
Respiratory physiotherapy، PCO2 value, PEEP changes, PCO2 waveforms, PCO2 release rate, History of pulmonary disease, history of smoking, level of consciousness, patient's drug use, history of physiotherapy,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181105041567N1
Registration date: 2018-12-10, 1397/09/19
Registration timing: registered_while_recruiting

Last update: 2018-12-10, 1397/09/19
Update count: 0
Registration date
2018-12-10, 1397/09/19
Registrant information
Name
Morteza Shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3890 6328
Email address
shahrokhim96@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of respiratory physiotherapy and peep changes on the results of capnography in patients with ventilator associated pnemonia.
Public title
The effect of respiratory physiotherapy and PEEP changes on the results of capnography.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 80 years The patient has a tracheal tube and is connected to a ventilator Patient with pneumonia associated ventilator with positive chip culture The patient is under the ventilator and has the parameter PEEP
Exclusion criteria:
A patient with systolic blood pressure of less than 90 mmHg Patient with rib fractures and chest tube Patient with high ICP Symptoms Patient with fracture of cervical and lumbar spine and preservation of immobility Patient with abdominal and chest surgeries
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method was available in this study and allocation of samples in two groups was randomized
Blinding (investigator's opinion)
Not 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 Sabzevar University of Medical Sciences
Street address
Campus, University of Medical Sciences, Nuclear Martyrs Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2018-10-31, 1397/08/09
Ethics committee reference number
IR.MEDSAB.REC.1397.050

Health conditions studied

1

Description of health condition studied
ventilator associated pnemonia.
ICD-10 code
J15.9
ICD-10 code description
Unspecified bacterial pneumonia

Primary outcomes

1

Description
Numerical value of capnography.
Timepoint
Beginning of study, In the minutes of one, five,ten, fifteen, thirty measurements.
Method of measurement
Capnograph machine

Secondary outcomes

1

Description
The shape of the capnographic waves.
Timepoint
Beginning of study, At minutes one, five, ten, fifteen and thirty are measured.
Method of measurement
Capnograph machine

Intervention groups

1

Description
Intervention group: The group in which we increase PEEP. We put PEEP ten for thirty minutes.
Category
Treatment - Devices

2

Description
Intervention group: A group that is undergoing respiratory physiotherapy for fifteen minutes.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashemi Nejad Hospital
Full name of responsible person
morteza shahrokhi
Street address
Hashemi Nejad Hospital, Mofatheh Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9152396451
Phone
+98 51 3273 7011
Fax
+98 51 3272 2322
Email
shahrokhimz68@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fershtee ghorrat
Street address
Prdis of Sabzevar University of Medical Sciences, Above the mazar shohaday ghomnam, shohaday hasteei Blvd.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Fax
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Morteza shahrokhi
Position
Masters Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 7, Sattari Street 22, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9152369874
Phone
+98 51 3890 6328
Email
shahrokhimz68@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Morteza shahrokhi
Position
Masters Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 7, Sattari Street 22, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9152369874
Phone
+98 51 3890 6328
Email
shahrokhimz68@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Morteza shahrokhi
Position
Masters Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 7, Sattari Street 22, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9152369874
Phone
+98 51 3890 6328
Email
shahrokhimz68@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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