Assessments of Diaphragm-pleural Mechanics During the Weaning From Prolonged Mechanical Ventilation

Respiratory Failure Clinical Trial

Official title:

Assessments of Diaphragm-pleural Mechanics During the Weaning From Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842280
• Other study ID #: 201811015RINA
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Weaning failure from mechanical ventilator is commonly seen in respiratory failure and increases duration of ventilator use, ICU stay, ventilator associated pneumonia and even mortality. The diaphragm serves as one of the most important respiratory mechanism and its function differs the weaning success rate. Since 1980s, ultrasonography assessment in diaphragm movement were developed and further discussion upon whether it serves as a predicting factor for extubation failure. The measurement includes difference of diaphragm thickness, diaphragm excursion or the movement of liver and spleen.

Multiple studies targeted intubated patients with different measurement methods and all resulted with good weaning prediction value.6 Of all the studies, only one study targeted tracheostomy tube patients. They reported diaphragm thickness fraction >36% as cutoff value is associated with successful spontaneous breathing trial (SBT), with a sensitivity of 0.82, specificity of 0.88. However, little comparison with traditional weaning parameters was mentioned in the study. We designed this prospective observational study to evaluate whether diaphragm movement under ultrasound serves as a predicting index of ventilator discontinuation in patients with tracheostomy. The diaphragm movement will also correlate with other parameters such as RSBI, Pi max, Pe max, Tv spont., WEANSNOW score(WS), VO2, APACHE II. Esophageal pressure is also provided as an option for our study population for more information such as pleural pressure, transdiaphragm pressure, etc.

The ultrasonography measurement of diaphragm movement will be performed within 6 hours before discontinuation of ventilator. The patient remains in semi-recumbent position with the convex probe selected for its good penetration. The probe is placed at a craniocaudal axis, 90 degrees to the skin at the lower intercostal spaces to right anterior axillary line (AAL) and left posterior axillary line (PAL), which allows a perpendicular ultrasound beam direction to the diaphragm movement. Liver (border or vascular structure), splenic (border or vascular structure) will be selected as target point and the marked distance of movement during quiet respiration cycle will be measured 10 times with a largest value calculated. Other echo measurements will also be attempted.

The study aims to investigate if the measurement of the diaphragm movement serves as a reliable predicting factor for weaning failure in respiratory care center patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Prolonged mechanical ventilation with tracheostomy tube

• Oxygen with a fraction of = 0.4

• Positive end expiratory pressure at = 5 cm H2O

• Pressure support at = 8 cmH2O

Exclusion Criteria:

• No spontaneous breathing

• Unstable hemodynamic status,

• History of peritonitis, intraabdominal operation, empyema, or pleurodesis.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency
• Ventilator Weaning

Intervention

Device:
• Diaphragm ultrasound assessment & Esophageal pressure measurement
Diaphragm ultrasound assessment and/or Esophageal pressure measurement before, during and after spontaneous breathing trial

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning success	Liberation from mechanical ventilation	1 month
Secondary	Ventilator free 30 days after liberation	No mechanical ventilation use in 30 days after liberation	30 days after liberation
Secondary	Ventilator free 60 days after liberation	No mechanical ventilation use in 30 days after liberation	60 days after liberation
Secondary	Ventilator free 90 days after liberation	No mechanical ventilation use in 90 days after liberation	90 days after liberation