Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation
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|ClinicalTrials.gov Identifier: NCT03561792|
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : January 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Weaning Failure||Other: Diaphragm ultrasound||Not Applicable|
The rapid shallow breathing index (RSBI), calculated from respiratory rate divided by tidal volume (RR/VT), is a well-known weaning index and one of the most clinical indices used to predict weaning outcome. However, it has some limitations in predicting weaning outcomes. Several previous studies have defined different sensitivities and specificities for RSBI less than 105 to predict weaning success which may lead to errors in predicting successful weaning.
On the other hand, Weaning failure is likely to occur if there is an imbalance between the load on the inspiratory muscles and their neuromuscular capacity, the imbalance between the mechanical load imposed on the diaphragm which is the major muscle of inspiration and its ability to cope with it. Therefore, evaluating the function of diaphragm before any weaning trial could be useful in predicting weaning outcome.
Bedside ultrasonography is an easy, fast, noninvasive, and accurate maneuver for evaluating diaphragmatic function. Diaphragmatic displacement (DD) reflecting the ability of diaphragm to produce force and subsequently tidal volume during inspiration and defined as displacement of less than 10 mm has been found to be a predictor of weaning failure among patients in medical ICUs.
Spadaro et al. proposed substituting VT with DD in the RSBI, and calculating diaphragmatic RSBI (DRSBI) would result in a more accurate predictive index than the traditional RSBI.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Masking Description:||The ICU team on charge takes the decision to continue spontaneous breathing trial (SBT) according to the local practice protocols which depends on the traditional RSBI (RSBI < 105 predicts successful weaning). The ICU team will not be allowed to know the results of diaphragmatic ultrasound.|
|Official Title:||Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation: Comparison With Traditional Rapid Shallow Breathing Index|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||October 1, 2018|
No Intervention: traditional RSBI
the decision to continue SBT depends on the traditional RSBI (RSBI < 105 predicts successful weaning)
Experimental: Diaphragmatic RSBI
diaphragm ultrasound was done to measure diaphragmatic displacement which is used to calculate DRSBI and The investigator takes the decision about SBT continuation based on the result of DRSBI (DRSBI < 1.3 predicts successful weaning)
Other: Diaphragm ultrasound
In the semi-sitting position ultrasonography for diaphragmatic displacement was performed by the same intensivist. Diaphragmatic movement was evaluated by using 2 to 5 MHz US probe (Sonosite M-Turbo machine). The right hemidiaphragm was examined by two-dimensional (2D) and M-mode to record diaphragm displacement.in M-mode, the diaphragmatic displacement (cm) was measured and then DRSBI was calculated by respiratory rate (RR)/ diaphragmatic displacement (DD) (in mm)
- weaning failure [ Time Frame: 48 hours ]weaning failure is the inability to maintain spontaneous breathing for at least 48 h, Patients who required reintubation or noninvasive positive pressure ventilation within 48 h of discontinuation of mechanical ventilation (MV) will be considered failed to wean
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561792
|Zagazig University Hospitals|
|Zagazig, Sharkia, Egypt, 44111|
|Study Director:||Essam F Abdelgalel, MD||Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University|
|Principal Investigator:||Sherif MS Mowafy, MD||Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University|