Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation

December 30, 2018 updated by: Sherif M. S. Mowafy, Zagazig University

Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation: Comparison With Traditional Rapid Shallow Breathing Index

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44111
        • Zagazig University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Essam F Abdelgalel, MD, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 30, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4664/28-5-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

from the study director

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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