A comparative study on the effect of two methods of pressure support setting on the respiratory distress in patients undergoing mechanical ventilation admitted in intensive care units
Determining and comparing the effect of two methods of pressure support setting on the respiratory distress
Design
A double-blind clinical trial with control and test groups (parallel); In this study, minimizing software is used for random allocation. Sample size 56.
Settings and conduct
This study is done at Al-Zahra Hospital with the aim of comparing the effect of two methods of pressure support setting on respiratory distress. In this study, the person who evaluates the results, participants and data analyzer are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients must be adult; being under mechanical ventilation with tachypnea and shallow breathing (the RSBI more than 105 breaths per minute per liter). Exclusion criteria: chronic obstructive pulmonary disease; acute respiratory distress syndrome, received neuromuscular blocking drug.
Intervention groups
In this study, in the first group (control group), pressure support is adjusted to such an extent that the total number of patient's breaths are less than 30 breaths per minute and the patient's tidal volume is 4-8 ml / kg. In the second group (test group), pressure support is adjusted to such an extent that the patient's rapid shallow breathing index is less than 105 breaths per minute per liter.
Main outcome variables
Respiratory distress observation scale and rapid shallow breathing index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200429047242N1
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Pooneh Barati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 6308
Email address
p.barati@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of two methods of pressure support setting on the respiratory distress in patients undergoing mechanical ventilation admitted in intensive care units
Public title
A comparative study on the effect of the two methods of pressure support setting on the respiratory distress in patients undergoing mechanical ventilation admitted in intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have to be under mechanical ventilation (SPONT mode);
The overall respiratory rate of the patients (breath which are delivered by the ventilator and spontaneous breath) must be more than 30 breaths per minute and the tidal volume of patient's breath have to be less than 4-8 ml/kg
The rapid shallow breathing index(RSBI) of the patients must be more than 105 breaths per minute per liter
Patients must be adult
The patient's respiratory distress observation scale must be more than 3
Exclusion criteria:
Chronic obstructive pulmonary disease and acute respiratory distress syndrome
Use of neuromuscular blocking drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two groups using minimization software. Age, sex, body mass index, analgesic use, sedative use, APACHE IV index rate and PEEP rate are given to minimization software to divide patients into two groups. Minimization (or Minimizer) is the name of a software used to divide samples among groups in clinical trials. In research projects, there are always variables that may affect the accuracy of the study (confounder variables); By entering these variables in this software, the variables are distributed among the research groups in such a way that there is the least difference between the groups, and for this reason, this method is preferable to the randomization method.This software has been installed on the website of Isfahan University of Medical Sciences at http://rct.mui.ac.ir/q/index.php; In this research we will use this website too.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind because in this study, the researcher (data collector and outcome assessor) first fill in the first part of the questionnaire and then the researcher's coworker (clinical caregiver; anesthesiologist) enters the data into the minimization software and then he sets pressure support by RSBI or " tidal volume and respiratory rate" method. The researcher fills the second and third parts of the questionnaire 15 and 30 minutes after setting the pressure support. The participant (patient), the researcher (data collector and outcome assessor) and the data analyst are not aware of how the samples are categorized. The draft of the article is prepared by the researcher too.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Approval date
2020-04-15, 1399/01/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.040
Health conditions studied
1
Description of health condition studied
patients under mechanical ventilation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
signs and indicators of respiratory distress
Timepoint
before setting the pressure support, 15 and 30 minutes after setting it
Intervention group: In this group, pressure support is adjusted to the extent that the patient's rapid shallow breathing index is less than 105 breaths per minute per liter, because when this index is less than 105, the patient does not have rapid and shallow breathing (respiratory distress) and this means that the pressure support is properly adjusted for the patient.
Category
Treatment - Devices
2
Description
Control group: In this group, the adjustment of pressure support is based on tidal volume and number of breaths. Pressure support is adjusted to the extent that the patient's breathing rate is less than 30 and his or her tidal volume is more than 4-8 ml / kg, because in this case the patient does not have respiratory distress; this means that the patient's pressure support is set correctly.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Somayeh Ghafari
Street address
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7540
Email
somayehghafari@NM.MUI.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Nursing and midwifery faculty, isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7540
Email
somayehghafari@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7540
Email
somayehghafari@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7540
Email
somayehghafari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery faculty, Isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7540
Email
somayehghafari@nm.mui.ac.ir
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