Protocol summary

Summary
First Step: A Control Group Of Patients In The ICU, 62 Patients Undergoing Mechanical Ventilation Are More Than 24 Hours As Controls Are Evaluated. Inclusion Criteria Included Age 80-18 Years, Absence Of Neurological And Neuropsychiatric Diseases - Muscular, Use The Minimum Dose Of Sedative Drugs (Light Relaxation Time Scale As Palma And Cooke 18-15) And No Addiction Opium. Information Required By The Tables And The Questionnaire Attached Proposal, Will Be Collected From The Records Of Patients Hospitalized In The ICU. At This Stage, the Researcher Is Present Only As Observers. The Primary Criterion's For The Separation Of Eight Patients In This Group Are: 1 - The Start of Mechanical Ventilation On The Sides Or Dropped. 2-CT <38.5 0 3 - Hb ≥ 8 gr / Dl 4 Pao2 ≥ 60 mmhg – 5 - Sao2 ≥? With Fio2 ≤ 40% 6 - PEEP ≤ 8 Cmh2o 7 - F / TV ≤ 105 8 - Use the Minimum Dose Of Drugs Sedative Before Separation, All Patients with PSV = 8-10 Cmh2o, PEEP = 5cmh2o, Fio2 <40% Were Ventilated According To The Physician, Patients Are Removed From The Device Under The SBT With A T-Piece With Are The Average Of 2 Hours. During The First Minutes before Separation with The ABG And Calculation, Cst, Rs, MV, Pao2 / Fio2 F / TV And ... Standard Index Of Separation: IWI = (Cst, Rs * Sao2) / (F / TV) Is Calculated. If There Are Favorable Conditions With Your Doctor, Extubation Is Performed. After Extubation, 48 Hours control Clinical Status Is Considered. Back To The Mechanical Ventilation For Patients With Medical Conditions That Are Completely Unaware Of The Study And The Index Is To Be Taken. Second Stage: The Eight Criteria IWI Index Separation And Isolation Of Patients To Physicians And Nurses In Charge Of The Mechanical Ventilator, Is Taught. The Other 62 Patients According To Inclusion Criteria Are Enrolled. Contextual Information from The Records Of The Mining Sector And Will Be Recorded. 8 The Primary Criterion For The Separation To Be Evaluated In Patients On A Daily Basis. All Patients Before Separation, With Fio2 <40% PEEP = 5cmh2o, PSV = 8-10 Cmh2o, And They Were Ventilated During The First Minutes Before Separation With The ABG And Calculate F / TV, Cst, MV, Pao2 / Fio2.The IWI Index Is Calculated By The Medical Team In Case Of IWI ≥ 25Conditions, With The Doctor, Patients With T-Piece SBT With An Average Period Of 2 Hours To Start. If There Is An Effective Cough (Subjective Evaluation By The Research Team) And The Stability Condition (Assessed Objectively By The Glasgow Scale 4 Score And GCS), Is The Readiness For Extubation. After Extubation, The Patient Is Evaluated For 48 Hours. Third Stage: The Rate of Successful and Unsuccessful Isolation of the Mechanical Ventilator in the Two Groups Are Compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203282996N9
Registration date: 2012-04-05, 1391/01/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-04-05, 1391/01/17
Registrant information
Name
Seyyed Davood Tadrisi
Name of organization / entity
Baghiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 9941
Email address
sdt1343@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqyatallah University of Medical Sinence
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the outcomes of Weaning with current methods and IWI-based in patients admitted to ICU of selected hospitals in Tehran During 2011-2012
Public title
Comparison the outcomes of Weaning with current methods and IW
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : - Patient >18 Years Up To 80 Years Old - ventilator time >24hr - Non neurological And Intramuscular Disease - None Or A Minimal Dose Of Sedative Drugs -Non Addiction , Heavy Smokers - Not Admitted In ICU-open heart Exclusion Criteria : - Use High Dose Of Sedative Drug - Auto- Extubation
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: 124
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqyatallah University of Medical Sinence
Street address
vanak-molasadra
City
tehran
Postal code
Approval date
2011-11-29, 1390/09/08
Ethics committee reference number
22-2249

Health conditions studied

1

Description of health condition studied
Patients in ICU
ICD-10 code
XXI
ICD-10 code description
XXI

Primary outcomes

1

Description
Lung Static Compliance
Timepoint
2 Time After Weaning Every 24 Hour
Method of measurement
Formula

Secondary outcomes

1

Description
Rapied shalow breathing index
Timepoint
2 time after weanning-evrey 24 hour
Method of measurement
Formula (f/tv)

Intervention groups

1

Description
The new index(iwi= compliance static*o2sat/(respiratory rate/tidal volume) Index measuring the isolation without physician is aware of its Doctor will measure current index Then the two methods in both sensitivity and specificity indices are compared. The range of each curve is determined and compared with the standard and the doctor would have told
Category
Treatment - Other

2

Description
The physician After ensuring the correctness of the indexmeasures the index and then separates the patient from the machine
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqyatallah hospital
Full name of responsible person
Davood Tadrissi
Street address
Vanak - Mullasarda - Sheikh Bahai South
City
Tehran

2

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Davood Tadrissi
Street address
piroze-takhte-Three ways Takhti
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqyatallah University of Medical Sinence
Full name of responsible person
sohel najafe Mehre
Street address
Aghdaseah, Araj, Valayat
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqyatallah University of Medical Sinence
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Baqyatallah University of Medical Sinence
Full name of responsible person
Davood Tadrissi
Position
Faculty member
Other areas of specialty/work
Street address
Aghdaseah, Araj, Valayat
City
Tehran
Postal code
Phone
+98 21 7732 8516
Fax
Email
sdt1343@yahoo.comsdt1343@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqyatallah University of Medical Sinence
Full name of responsible person
Davood Tadrissi
Position
Faculty member
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 7732 8516
Fax
Email
sdt1343@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqyatallah University of Medical Sinence
Full name of responsible person
Davood Tadrissi
Position
Faculty member
Other areas of specialty/work
Street address
Aghdaseah, Araj, Valayat
City
Tehran
Postal code
Phone
+98 21 7732 8516
Fax
Email
sdt1343@bmsu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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