Evaluation of the effect of using Airway Pressure Release Ventilation (APRV) in comparison with Pressure Support Ventilation (PSV) method in lung mechanics in patients with Acute Respiratory Failure (ARF) admitted to intensive care unit
Evaluation of the effect of using APRV in comparison with PSV in lung mechanics in patients with respiratory failure admitted to intensive care unit
Design
A randomised clinical trial with a control group, with parallel, unblinded, randomized groups on 52 patients. A computer-generated random number table is used for randomization
Settings and conduct
In the APRV and PSV group,if the following conditions are present, patient is extubated: RSBI <105, pulmonary compliance above 40, resistance less than10, SBP> 90
Participants/Inclusion and exclusion criteria
Patients with acute type I respiratory failure with endotracheal intubation and mechanical ventilation for less than 48 hours are admitted based on P / F Ratio = 150-250؛ Patients with neuromuscular or diaphragmatic disorder or chest deformity or suspected intracranial hypertention or chronic obstructive pulmonary disease or severe asthma or chronic heart failure or chronic renal failure or refractory shock or diagnosed barotrauma or lungs contusion or under 16 years of age and over 85 years, or pregnancy or abdominal compartment syndrome are excluded
Intervention groups
Intervention group :Patients switch from previous PSV ventilation mode to APRV mode. PaO2 above 60.The T-low is set to 1 to 1.5 times the expiratory time constant (TE).T-high is adjusted so that the release frequency is set to 10-14 / min and PaCO2 is kept in the normal range.Control group:Pressures are applied on the pressure mode with PIP and PS with the aim of creating a tidal volume equal to 6ml / kg of predicted body weight and PEEP is adjusted to the extent that with FIO2 less than 60%, PaO2 above 60.In both age and sex groups,IBW and APACHEII Score at the time of hospitalization and lung mechanics and ventilator and oxygenation settings(P / F Ratio) and ABG indices are recorded on days1, 2, 3 and 7.
Main outcome variables
Lung mechanics؛compliance,resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047376N1
Registration date:2020-11-24, 1399/09/04
Registration timing:registered_while_recruiting
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
arash najafi abrandabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 5720
Email address
najafiarash@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-12, 1399/08/22
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using Airway Pressure Release Ventilation (APRV) in comparison with Pressure Support Ventilation (PSV) method in lung mechanics in patients with Acute Respiratory Failure (ARF) admitted to intensive care unit
Public title
The effect of APRV ventilation mode on respiratory failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intubated patients with acute respiratory failure type I (hypoxemic)
Endotracheal intubation and mechanical ventilation less than 48 hours
Respiratory failure based on P / F Ratio = 150-250
Exclusion criteria:
Patients with acute respiratory failure and P / F Ratio less than 150
Neuromuscular and diaphragmatic disorders
Chest deformity
Suspected Intracranial Hypertension
COPD and severe asthma
CHF
CKD , ESRD
Refractory shock
Diagnosed Barotrauma and Lung Contusion
Age under 16 and over 85 years
Pregnancy
Abdominal compartment syndrome
Age
From 16 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The two groups are divided based on random numbers generated by computer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sina Hospital, Imam Khomeini Ave.,Imam Khomeini Square
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.848
Health conditions studied
1
Description of health condition studied
Acute hypoxemic respiratory failure
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
Lung compliance. Lung resistance
Timepoint
Measurement of lung compliance and resistance on days 1, 2, 3 and 7 after long-term onset of APRV and PSV
Method of measurement
compliance and resistance measurment is based on ventilator information
Secondary outcomes
1
Description
Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Scoring System
Timepoint
At the time of admission
Method of measurement
According to the case report
2
Description
Oxygenation based on the ratio of arterial oxygen pressure to the Fio2
Timepoint
Days 1, 2, 3 and 7 after the start of ventilation mode
Method of measurement
Based on sample information of ABG blood gas analysis
3
Description
Arterial blood carbon dioxide pressure PaCO2
Timepoint
Days 1, 2, 3 and 7 after the start of ventilation mode
Method of measurement
Based on sample information of ABG blood gas analysis
4
Description
Fentanyl intake
Timepoint
روزهای 1و2و3و7 بعد از شروع مد تهویه ای
Method of measurement
Based on patient record (micrograms)
5
Description
number of ventilator free days at day 28
Timepoint
Twenty-eighth day after intervention
Method of measurement
Based on patient record
6
Description
Intensive care unit length of stay
Timepoint
At the time of discharge from the intensive care unit
Method of measurement
Based on patient record
7
Description
Richmond Agitation and Sedation Scale (RASS score)
Timepoint
Days 1, 2, 3 and 7 after the start of ventilation mode
Method of measurement
Based on patient record
8
Description
The amount of shunt: (1-SaO2)/(1-SvO2)
Timepoint
Days 1, 2, 3 and 7 after the start of ventilation mode
Method of measurement
Based on ABG information
Intervention groups
1
Description
Intervention group: APRV: Patients change from previous volume ventilation mode to APRV mode. P-high is adjusted to create VT = 6ml / kg and does not exceed 30cmH2O. From 60%, produce PaO2 above 60. The T-low is set to 1 to 1.5 times the expiratory time constant (TE). T-high is adjusted so that the release frequency is set to 10-14 / min and PaCO2 is maintained in the normal range.
Category
Treatment - Devices
2
Description
Control group: PSV: Patients on pressure mode with PIP and PS with the aim of creating a tidal volume equal to 6 ml per kg of ideal weight. PEEP to the extent that with FIO2 less than 60%, PaO2 above 60 Slowly adjusted.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Arash Najafi Abrand Abadi
Street address
Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
najafiarash2005@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Faculty of Medicine,Tehran University of Medical sciences, Poorsina street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
najafiarash2005@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elham Naseh
Position
ICU fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Science, Poorsin street, Keshavarz ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 84901
Fax
+98 21 8863 3039
Email
elhamnaseh63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atabak Najafi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
elhamnaseh63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Naseh
Position
ICU fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Science, Poorsin street, Keshavarz ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 84901
Fax
+98 21 8863 3039
Email
elhamnaseh63@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data is recorded and archived in the datasheet. All data can be shared after unidentifiable study subjects.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
No other analysis is allowed.
From where data/document is obtainable
En To receive the data, they can send a request to the following email address. elhamnaseh63@gmail.com
What processes are involved for a request to access data/document
En To receive the data, they can send a request to the following email address. elhamnaseh63@gmail.com. Information will be made available to eligible individuals within 24 hours.