The main goal of this study is to evaluate the effect of diaphragmatic ultrasonography on the success of extubation (weaning from mechanical ventilation) in patients admitted to the Intensive Care Unit.
Design
This study is designed as a double-blinded randomized clinical trial. 60 mechanically ventilated respiratory ICU patients who meet the inclusion criteria will be randomly allocated into two groups of 30 (intervention and control groups). In the intervention group, in addition to usual methods, diaphragmatic ultrasonography will also be performed.
Settings and conduct
60 mechanically ventilated respiratory ICU patients who meet the inclusion criteria will be randomly allocated into two groups of 30 (intervention and control groups). In the intervention group, in addition to usual methods, diaphragmatic ultrasonography will also be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years
Admitted to ICU due to respiratory failure
under mechanical ventilation
exclusion criteria:
Having neuromuscular disease
Presence of pleural effusion
Decreased level of consciousness
Intervention groups
The intervention group includes 30 eligible patients who are randomly selected.
In addition to standard methods for assessing readiness for extubation (e.g. RSBI index), patients in the intervention group undergo diaphragmatic ultrasonography performed by the study investigator (anesthesia resident).
In the diaphragmatic ultrasound, the movement and thickness of the diaphragm are measured in M-mode.
The findings from the diaphragmatic ultrasound serve as the basis for deciding whether the patient is ready for extubation.
Main outcome variables
Main outcome measures including rates of successful extubation, duration of extubation and ICU length of stay will be compared between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190215042716N5
Registration date:2023-12-20, 1402/09/29
Registration timing:prospective
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
navid shafigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3378
Email address
n.shafigh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of movement and thickness of diaphragm measured by ultrasound on weaning success in patients admitted to Intensive Care Unit
Public title
Evaluation of movement and thickness of diaphragm measured by ultrasound on weaning success in patients admitted to Intensive Care Unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Admitted to ICU due to respiratory failure
Under mechanical ventilation
Meeting the extubation criteria
Exclusion criteria:
Having neuromuscular disease
Presence of pleural effusion
Decreased level of consciousness
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After initial screening and selecting 60 eligible patients based on the inclusion and exclusion criteria, their baseline and demographic information will be recorded.
The APACHE II and SOFA scores of the patients will be calculated to determine the severity of their illness.
The patients will be compared in terms of illness severity, and 30 patients with similar severity will be placed in group A and 30 other patients with similar severity in group B.
Then, using a random number generation software, group A will be selected as the intervention group and group B as the control group.
This is how patients will be randomly allocated to the two 30-people intervention and control groups.
Finally, the intervention will be applied to the intervention group and the results will be compared with the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed as a double-blinded randomized clinical trial. This means that not only are the patients unaware of their allocation to either the intervention or control group, but the treating physicians and nurses are also blinded to the patient allocation .Therefore, neither the patient nor the treating physician/nurse know which group the patient is allocated to. This is done to eliminate bias in the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Main outcome measures including rates of successful extubation, duration of extubation and ICU length of stay will be compared between the two groups.
Timepoint
one weak
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group includes 30 eligible patients who are randomly selected. In addition to standard methods for assessing readiness for extubation (e.g. RSBI index), patients in the intervention group undergo diaphragmatic ultrasonography performed by the study investigator (anesthesia resident). In the diaphragmatic ultrasound, the movement and thickness of the diaphragm are measured in M-mode. The findings from the diaphragmatic ultrasound serve as the basis for deciding whether the patient is ready for extubation
Category
Treatment - Devices
2
Description
Control group: The control group contains 30 patients similar to the intervention group in terms of demographic characteristics and illness severity, selected randomly. In this group, patients receive standard existing care in the ICU and diaphragmatic ultrasonography is not performed. The criteria for deciding on extubation is also based on standard methods.