se of ultrasound to determine changes in diaphragm mechanics during a spontaneous breathing trial

Not Applicable

• Conditions: Weaning from mechanical ventilation; Respiratory failure; Diaphragmatic dysfunction; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12616000596404
• Lead Sponsor: Dr Hayden White

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-09
• Study Completion: 2018-02-04
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

* Patient intubated and mechanically ventilated for at least 24 hours over the age of 18
* Planned to undergo spontaneous breathing trial as per unit protocol

Exclusion Criteria

* Neuromuscular disease likely to result in diaphragmatic dysfunction
* Inability to visualise diaphragm on ultrasound
* Inability to access right chest wall due to dressings or surgical site
* Inability to sit at 45 degrees
* Diaphragmatic injury as a result of trauma or surgery
* Pregnancy
* Unilateral diaphragmatic or phrenic nerve pathology
* Patients whom life support would be withheld, withdrawn, or who are not expected to survive their ICU admission

Specific to Edi patients
* Nasogastric catheter placement contra-indicated
* Inability to place Edicatheter
* Edi capable ventilator not available

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragmatic activity over the course of a spontaneous breathing trial measured by ultrasound <br> Ultrasound derived parameters <br>* Diaphragm thickness at end inspiration and end expiration <br>* Diaphragmatic thickening fraction- (Thickness at end inspiration - Thickness at end expiration) / Thickness at end expiration <br>* Diaphragmatic excursion (DE) - displacement measured in cm <br>* Diaphragmatic contraction speed measured in cm/s[Measured at 5 minutes and 30 minutes during SBT <br> In the event of SBT failure, prior to recommencement of mechanical ventilation if safe];Outcome of SBT (success / failure)<br><br>Success determined by remaining on T-piece for >30 minutes <br>Failure determined by need to return to mechanical ventilation <30 miutes due to RR > 38 (or >50% increase from baseline), HR >140 (or >25% increase from baseline), SBP 40mmHg above baseline or anxiety/agitation, cardiac arrhythmias or respiratory acidosis[Recorded at conclusion of SBT]

Secondary Outcome Measures

Name	Time	Method
Extubation success or failure<br><br>Determined by review of clinical records<br>Success if patient remains extubated at 48 hours<br>Failure if patient required re-intubation or passes away secondary to recurrent respiratory failure (in a patient deemed not for re-intubation)[48 hours post SBT]