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

Primary Purpose

Weaning Failure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Diaphragm ultrasound
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weaning Failure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zagazig University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

traditional RSBI

Diaphragmatic RSBI

Arm Description

the decision to continue SBT depends on the traditional RSBI (RSBI < 105 predicts successful weaning)

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)

Outcomes

Primary Outcome Measures

weaning failure
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

Secondary Outcome Measures

Full Information

First Posted
June 5, 2018
Last Updated
December 30, 2018
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03561792
Brief Title
Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation
Official Title
Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation: Comparison With Traditional Rapid Shallow Breathing Index
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weaning Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
traditional RSBI
Arm Type
No Intervention
Arm Description
the decision to continue SBT depends on the traditional RSBI (RSBI < 105 predicts successful weaning)
Arm Title
Diaphragmatic RSBI
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Diaphragm ultrasound
Intervention Description
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 Measure Information:
Title
weaning failure
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essam F Abdelgalel, MD
Organizational Affiliation
Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherif MS Mowafy, MD
Organizational Affiliation
Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University Hospitals
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
from the study director
Citations:
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Citation
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Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation

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