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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
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, Zagazig University

Brief Summary:
Predicting successful discontinuation from mechanical ventilation has been a focus of interest to all critical care physicians . Various weaning indices have been investigated to optimize the weaning process. Among them, the rapid shallow breathing index (RSBI) has gained wide use but it have different sensitivities and specificities. By substituting tidal volume (VT) with diaphragmatic displacement (DD) in the calculation of RSBI a new index (the diaphragmatic rapid shallow breathing index DRSBI) was proposed and it was independently associated with weaning failure and its accuracy for predicting weaning outcome is expected to be superior to the traditional RSBI.

Condition or disease Intervention/treatment Phase
Weaning Failure Other: Diaphragm ultrasound Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient or relative acceptance
  • Mechanically ventilated for more than 48 hours
  • Ready to wean and at their first spontaneous breathing trial
  • meeting all weaning criteria

Exclusion Criteria:

  • history of any neuromuscular disease
  • diaphragmatic palsy
  • cervical injury
  • current chest trauma
  • thoracotomy for any reason
  • patients in whom neuromuscular blockers are used in the last 48 hours before the study
  • patients for whom aminoglycosides are prescribed during their course in ICU

Information from the National Library of Medicine

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


Locations
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Egypt
Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44111
Sponsors and Collaborators
Zagazig University
Investigators
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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
Publications:

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Responsible Party: Sherif M. S. Mowafy, Lecturer of Anesthesia and Surgical Intensive Care, Zagazig University
ClinicalTrials.gov Identifier: NCT03561792    
Other Study ID Numbers: 4664/28-5-2018
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: starting 6 months after publication
Access Criteria: from the study director

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes