The effect of APRV-LTV mechanical ventilation mode on arterial blood gases, ventilation indices and vital signs in patients with COVID-19
Design
Randomized clinical trial, with a control group, parallel groups. The sample size is 70 patients that randomly will be assigned to control and intervention groups using the block randomization method.
Settings and conduct
This study will be performed in the critical care unites of Shahid Beheshti Hospital in Qom. No blinding will be performed in this study. Patients in the control group will be ventilated using SIMV mechanical ventilation mode. Patients in the intervention group will be ventilated using APRV-LTV mechanical ventilation mode. Patients' respiratory indicators and vital signs will be measured in the stages of immediately before and 2 and 4 hours after starting the ventilation.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: age over 18 years; having informed consent to participate in the study.
Intervention groups
Patients in the intervention group will be ventilated using APRV-LTV mechanical ventilation mode. Patients in the control group will be ventilated using SIMV mechanical ventilation mode.
Main outcome variables
Stabilization of vital signs and respiratory indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150724023314N4
Registration date:2021-09-04, 1400/06/13
Registration timing:prospective
Last update:2021-09-04, 1400/06/13
Update count:0
Registration date
2021-09-04, 1400/06/13
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3242 4753
Email address
mabasiniya@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of APRV-LTV mechanical ventilation mode on arterial blood gases, ventilation indices and vital signs in patients with COVID-19
Public title
The effect of APRV-LTV mechanical ventilation mode in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
No history of chronic respiratory diseases such as COPD
Having a endotracheal tube and being connected to mechanical ventilation
Exclusion criteria:
The patient refuses to participating in the study
Instability of the patient's vital signs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (100 samples including sample loss), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the 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 Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.MUQ.REC.1400.065
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Blood pressure
Timepoint
Immediately before, 2 and 4 hours after the start of ventilation
Method of measurement
Vital Sign Monitoring Device
2
Description
Heart rate
Timepoint
Immediately before, 2 and 4 hours after the start of ventilation
Method of measurement
Vital Sign Monitoring Device
3
Description
Respiratory rate
Timepoint
Immediately before, 2 and 4 hours after the start of ventilation
Method of measurement
Vital Sign Monitoring Device
4
Description
Static compliance rate
Timepoint
Immediately before, 2 and 4 hours after the start of ventilation
Method of measurement
Vital Sign Monitoring Device
5
Description
PaO2 / FiO2 ratio
Timepoint
Immediately before, 2 and 4 hours after the start of ventilation
Method of measurement
Vital Sign Monitoring Device
6
Description
Arterial blood oxygen saturation
Timepoint
Immediately before, 2 and 4 hours after the start of ventilation
Method of measurement
Vital Sign Monitoring Device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: from 24 hours after the start of mechanical ventilation for 7 days, every morning, patients were ventilated for 4 hours in APRV-LTV mode.
Category
Other
2
Description
Control group: from 24 hours after the start of mechanical ventilation for 7 days, every morning, patients were ventilated for 4 hours in SIMV mode.