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The effect of Automatic Tube Compensation on internal PEEP in Chronic Obstructive Pulmonary Disease in Intensive Care Unit.

Protocol summary

Study aim
The effect of Automatic Tube Compensation on internal PEEP in Chronic Obstructive Pulmonary Disease in Intensive Care Unit.
Design
This study is a clinical trial that is performed randomly using available samples and has not been blinded. The sample size is 60 patients using a specific formula. Variables are measured on patients before and after the intervention.
Settings and conduct
This study is performed in Rasoul Akram Hospital in Tehran. The following steps are performed for each patient three times in the morning, evening and night: First, the patient's airway is suctioned so that the airway pressure does not change due to secretions.Then, before activating the ATC mode, once every 6 seconds for 1 minute, the patient's initial internal PEEP value is recorded and its average is listed in the checklist. Then the ATC mode is activated and after one minute from the start of the ATC mode for one minute, the internal PEEP is recorded every 6 seconds and its average is taken and 6 minutes later, the process is repeated until the average internal PEEP is recorded 6 times after ATC is activated and variables are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Written consent of an effective member of the patient's family, The patient should be Intubated and connected to a ventilator, Do not change the ventilator settings during the intervention.Exclusion criteria: King Endotracheal Tube during study, Perform suction during the intervention, Leakage from the Endotracheal Tube cuff.
Intervention groups
In this study, the effect of ATC on the rate of internal PEEP of COPD in the ICU will be investigated.samples of the study are both control group and intervention group, so that before the ATC fashion, patients are in the control group and after the ATC fashion, they are in the intervention group.
Main outcome variables
Internal PEEP value, age, sex

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170903036041N2
Registration date: 2020-05-15, 1399/02/26
Registration timing: prospective

Last update: 2020-05-15, 1399/02/26
Update count: 0
Registration date
2020-05-15, 1399/02/26
Registrant information
Name
Omid Moradi Moghadam
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
moradimoghadam.o@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Automatic Tube Compensation on internal PEEP in Chronic Obstructive Pulmonary Disease in Intensive Care Unit.
Public title
The effect of Automatic Tube Compensation on internal PEEP in Chronic Obstructive Pulmonary Disease in Intensive Care Unit.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent of an effective member of the patient's family The patient should be intubated and connected to a ventilator. Do not change the ventilator settings during the intervention.
Exclusion criteria:
King Endotracheal Tube during study Leakage from the Endotracheal Tube cuff Perform Suction during the intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.IUMS.FMD.REC.1399.096

Health conditions studied

1

Description of health condition studied
COPD
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Internal PEEP
Timepoint
Before and after ATC mode
Method of measurement
View from the monitor screen of the ventilator

Secondary outcomes

1

Description
Age
Timepoint
Before doing the study
Method of measurement
Patient file

2

Description
Sex
Timepoint
Before doing the study
Method of measurement
Patient file

Intervention groups

1

Description
Intervention group: This study is a clinical trial that is performed randomly using available samples and the effect of ATC on the internal PEEP rate of COPD patients in the ICU will be investigated. In the first group, before activating the ATC mode, the patient's airway is suctioned so that the airway pressure does not change due to secretions, then once every 6 seconds for 1 minute the initial internal PEEP value is recorded and its average is listed in the checklist. To do this study, we use the Hamilton c2 ventilator.
Category
Treatment - Devices

2

Description
Intervention group: This study is a clinical trial that is performed randomly using available samples and the effect of ATC on the internal PEEP rate of COPD patients in the ICU will be investigated. In the second group, the ATC mode is activated, and one minute after the start of the ATC mode, the internal PEEP is recorded every 6 seconds for one minute and its average is taken. This process is repeated 6 minutes later until the average internal PEEP is recorded 6 times after ATC activation.To do this study, we use the Hamilton c2 ventilator.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Omid Moradi Moghadam
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6653 9233
Email
moradimoghadam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Omid Moradi Moghadam
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6653 9233
Email
moradimoghadam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Omid Moradi Moghadam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6653 9233
Email
moradimoghadam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Omid Moradi Moghadam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6653 9233
Email
moradimoghadam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahab mohammadi
Position
Doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6653 9233
Email
Shahabmohammadi606@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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