Comparison between the cough peak expiratory flow measurement and the cough strength measurement with white paper test on the success of extubation in ICU patients.
Comparison between the cough peak expiratory flow measurement and the cough strength measurement with white paper test on the success of extubation.
Design
Clinical trial with control and parallel group, without blinding, random assignment to groups is based on random sequence generated by SPSS software.
Settings and conduct
Intubated patients in the ICU of Imam Reza Hospital, are divided into two groups: control (routine) and intervention. In the control group, the cough strength of the patient is measured by observing the piece of white paper which is moistened after 3 coughs through the tracheal tube. In the intervention group, cough strength is measured quantitatively using the Bellavista 1000 ventilator. In both groups, 24 and 48 hours after extubation, patients are examined for re-intubation criteria.
Participants/Inclusion and exclusion criteria
Inclusion: Be alert based on RASS scale (0 or 1). between 18-60 years. Spontaneous breathing more than 30 minutes. Suctioning is required every two hours or more. Mechanical ventilation longer than 24 hours.
Exclusion: Lack of co-operation or inability to cough, Symptoms of tracheal stenosis, Aspiration within 24 hours before extubation, Hearing or visual problems, Start sedative drugs for patient.
Intervention groups
In the intervention group, the cough strength will be quantitatively measured by the Ventilator Bellavista 1000/e.
In the control, the cough strength is assessed by white paper test.
Main outcome variables
extubation success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171224038028N1
Registration date:2018-07-07, 1397/04/16
Registration timing:registered_while_recruiting
Last update:2018-07-07, 1397/04/16
Update count:0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
Mohsen Abedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3527 4561
Email address
Abedinim951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-14, 1397/02/24
Expected recruitment end date
2018-11-15, 1397/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the cough peak expiratory flow measurement and the cough strength measurement with white paper test on the success of extubation in ICU patients.
Public title
Comparison between the cough peak expiratory flow measurement and the cough strength measurement with white paper test on the success of extubation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be alert based on RASS scale (0 or 1)
Be admitted in ICU with diagnosis of internal disease.
Age between 18-60 years.
Spontaneous breathing more than 30 minutes.
Suctioning is required every two hours or more.
Mechanical ventilation longer than 24 hours.
Exclusion criteria:
Lack of co-operation or inability to cough
Exacerbation of the disease before extubation
Mental disorders and delirium
Tracheal stenosis
Having a tracheostomy
Aspiration within 24 hours before extubation
Hearing problems (deaf, despite the use of auxiliary equipment) and visual problems.
Start sedative drugs for patient.
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment using random sequence generated by SPSS software is implemented to select patients for intervention and control group.
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 Mashhad University of Medical Sciences
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.MUMS.REC.1397.041
Health conditions studied
1
Description of health condition studied
Respiratory failure, unspecified
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified
Primary outcomes
1
Description
Extubation success
Timepoint
24 and 48 hours after weaning
Method of measurement
Measuring blood oxygen saturation
Secondary outcomes
empty
Intervention groups
1
Description
The patient which is ready for extubation, is connected to the ventilator with supportive mode. Then he is asked to cough three times. In this case, the peek expiratory flow rate of these coughs is calculated by the Bellavista 1000 ventilator.
Category
Diagnosis
2
Description
Control group: Based on the routine method, for the patient which is ready for extubation, a piece of white paper is kept at a distance of 1-2 cm from the endotracheal tube. The patient is then asked to cough three times.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Razieh Froutan
Street address
Ebn-e-Sina Street, Imam Reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
froutanr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Ghoreishi building.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Abedini
Position
Ms.C student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of nursing, Ibn-e-sina street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 919 442 0511
Email
Abedini.mohsen.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Abedini
Position
Ms.C student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of nursing, Ibn-e-sina street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 919 442 0511
Email
Abedini.mohsen.s@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Abedini
Position
Ms.C student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of nursing, Ibn-e-sina street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 919 442 0511
Email
Abedini.mohsen.s@gmail.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 not 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
No - There is not 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