Effect of the heat and moisture exchanger (HME)Filter and heated Humidifier on respiratory mechanics and gas exchange in patients undergoing mechanical ventilation with CPAP mode in intencive care units .
Comparison the effect of HME filter and heated humidifiers on gas exchange and lung mechanical parameters in patients undergoing mechanical ventilation with CPAP mode.
Design
Cross-over clinical trial In two groups with sample size of 21 persons
Samples were selected as available and randomly assigned to one of two groups.
Settings and conduct
Research Environment:
Intensive care units, strokes and general strokes of Ghaem Hospital.
In the first group, the HME filter is first connected to the ventilation path of the patients and the numerical values of gas exchange and lung mechanical parameters At fifteen and thirty and Sixty minutes, as shown by the ventilator monitor, are recorded on the chart and then subjected to humidification with respiratory air humidification.And after 30 minutes, numerical values of gas exchange and lung mechanical indexes are recorded on the chart in minutes, fifteen thirty and sixty, as shown by the ventilator monitor.In the second group, it is time to switch tools.
.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age 18 - 85 years
2. Patient with endotracheal tube and tracheostomy under CPAP
4- Patients with hemodynamic stability
5. RASS score between +1 and -4.
Exclusion criteria:
1- Having active hemoptysis or tracheal fistula
2 - systolic blood pressure< 90 mm Hg
Intervention groups
In the intervention group and control group the effect of HME filter and heated humidifiers on gas exchange and Indicators of lung mechanics are reviewed.
Main outcome variables
Exhaust end carbon dioxid,Alveolar ventilation, Respiratory dead space ventilation,Static compliance, Dynamic compliance,inspiratory Resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191112045414N1
Registration date:2020-01-19, 1398/10/29
Registration timing:registered_while_recruiting
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Elyas Motamedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3851 4261
Email address
elyas4383@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the heat and moisture exchanger (HME)Filter and heated Humidifier on respiratory mechanics and gas exchange in patients undergoing mechanical ventilation with CPAP mode in intencive care units .
Public title
Effect of the heat and moisture exchanger (HME)Filter and heated Humidifier on respiratory mechanics and gas exchange in patients undergoing mechanical ventilation with CPAP mode
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with tracheo tube or tracheostomy
patients under mechanical ventilation
patients with stable hemo dynamic status
Richmond score within +1 and -4
Exclusion criteria:
patients under mechanical ventilation expect of CPAP mode
Patients hospitalized due to hemoptesis
blood pressure under 90 mmHg
Patient with rib fracture or chest tube
Patient under surgery
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected as available and then assigned to either the HME group or the heated humidifier based on Permuted Block Randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
University of Medical sciences .Shohada Hastee Blv.Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2019-11-01, 1398/08/10
Ethics committee reference number
IR.MEDSAB.REC.1398.058
Health conditions studied
1
Description of health condition studied
Patients under mechanical ventilation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
respiratory mechanic and gas exchange
Timepoint
Beginning of the research and minutes 15،30،60
Method of measurement
Capnograph
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the first group, the HME filter is first connected to the ventilation path of the patients and the numerical values of gas exchange and lung mechanical parameters At fifteen and thirty and Sixty minutes, as shown by the ventilator monitor, are recorded on the chart and then subjected to humidification with respiratory air humidification.And after 30 minutes, numerical values of gas exchange and lung mechanical indexes are recorded on the chart in minutes, fifteen thirty and sixty, as shown by the ventilator monitor.
Category
Treatment - Devices
2
Description
Control group: In the second group,the humidifier is first connected to the ventilation path of the patients and the numerical values of gas exchange and lung mechanical parameters At fifteen and thirty and Sixty minutes, as shown by the ventilator monitor, are recorded on the chart and then subjected to the HME filter .And after 30 minutes, numerical values of gas exchange and lung mechanical indexes are recorded on the chart in minutes, fifteen thirty and sixty, as shown by the ventilator monitor.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Gaeem hospital
Full name of responsible person
Elyas Motamedi
Street address
Ahmadabad Ave .Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2626
Email
Elyas4383@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Alireza Moslem
Street address
Shohada Hasteei Blv
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1004
Email
drhassanpour@medsab.ac.ir
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
50
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
Elyas Motamedi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaeem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
0098 51 338012623
Email
elyas4383@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Basiri
Position
Physician
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmadabad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2663
Email
basirireza@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elyas Motamedi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahmadabad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2623
Email
elyas4383@gmail.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