Ultrasonography for Prediction of Extubation Success: a Holistic Approach (APEX)

This study evaluates thickening fraction alone and together with other ultrasound parameters of heart and lungs as predictors for extubation outcome

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Exutbation Failure
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

Weaning patients in the intensive care unit (ICU) from the mechanical ventilator is a critical period and accounts for 40% of the duration of mechanical ventilation itself. Weaning failure includes failing the initial spontaneous breathing trial (SBT) and patients with extubation failure. Extubation failure is defined as reintubation or need for rescue non-invasive ventilation within 48 hours following extubation. Patients failing extubation experience increased time spent on the mechanical ventilator and even increased mortality rates. Given these risks, predicting readiness for extubation is of key importance in the ICU.

Studies have shown, that US is a viable tool for routine use due to its bedside availability and non-invasiveness, while still maintaining excellent predictive values for its respective applications. For this reason, over the past years, critical care ultrasonography (US) has become an important part of routine bedside assessment Lately, the diaphragm has been studied extensively, due to its strong role in sustaining spontaneous breathing. Especially predicting extubation outcomes

has become a great field of interest and different studies have been conducted on this topic. Currently, indices such as diaphragm thickening (Tdi), diaphragm thickness (Tdi%) and diaphragm motion are the most frequently used parameters. Of these, thickening fraction seems to be the most promising to predict successful extubation.

However, all of the studies conducted, solely looked at diaphragm function and compared them to current standards such as the rapid shallow breathing index, while disregarding other factors strongly correlated to extubation failure, e.g. respiratory and cardiac function, as proposed by Mayo et al. Taking heart and lung function into account as well seems to be an interesting approach, because additional measurements could possibly improve predictive value while putting no further burden on the patient. Furthermore, both heart and lungs can be assessed quickly and easily by ultrasound. Cardiac parameters that are potentially useful are left ventricular function, mitral diastolic inflow and cardiac output. Regarding the lungs, pleural effusion is associated with rate of success for extubation. Effusion is detected easily and recent studies have shown, that in an ICU setting a simple 8 region protocol is sufficient to detect extra vascular lung water.

The investigators hypothesise that a holistic US approach, including measurements of heart, lungs and diaphragm, will be superior to the core diagnostic parameters of the diaphragm in predicting extubation success in mechanically ventilated critical care patients.

• Study Type: Observational
• Enrollment (Actual): 83

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consisted of adult (>18 years) patients, admitted to the ICU and ventilated for at least 72h.

Description

Inclusion Criteria:

• Ventilated for > 72 hours
• Passed spontaneous breathing trial

Exclusion Criteria:

• Planned NIV
• Palliative Extubation
• Tracheostomy
• Paraplegia above Th 8

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ventilated72h; Patient that were ventilated for at least 72 hours	Diagnostic test: Ultrasound; Point of care ultrasound as part of routine physical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity of thickening fraction for extubation failure	48 hours
Specificity	Specificity of thickening fraction for extubation failure	48 hours
Area under the Curve	Area under the receiver operator curve	48 hours
Correlation of ultrasound variables with extubation outcome	Correlation of ultrasound variables with extubation outcome through (logistic)regression analysis.	48 hours

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• Haaksma ME, Smit JM, Heldeweg M, Nooitgedacht JS, Atmowihardjo LN, Jonkman AH, de Vries HJ, Lim EH, Steenvoorden T, Lust E, Girbes AR, Heunks LM, Tuinman PR. Holistic Ultrasound to Predict Extubation Failure in Clinical Practice. Respir Care. 2021 Jun;66(6):994-1003. doi: 10.4187/respcare.08679. Epub 2021 Apr 13.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 29, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Diaphragm; Extubation; Holistic
• Other Study ID Numbers: 2016.465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon we request we can share our data to assist other researchers with interest in this field of research.
• IPD Sharing Time Frame: After publication in a peer reviewed journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No