Diaphragmatic Ultrasound to Predict NIV Outcome in Patients With De-novo ARF

NCT02976233 | Unknown

• 1 other identifier: ECONIV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Over the last two decades, non-invasive ventilation (NIV) has been widely reported as an effective method to avoid the need of endotracheal intubation (ETI) and improve survival in the acute care setting. Given the risks associated with either premature NIV discontinuation or delays in NIV interruption, evaluating readiness to weaning from NIV is a critical challenge in patients with Acute Respiratory Failure (ARF). Up to date, bedside measurements used to predict NIV outcomes are extremely limited. NIV weaning as well as decision of ETI are mainly supported by clinical and physiologic parameters. More sophisticated techniques used to predict weaning outcome during spontaneous breathing trials have never achieved a bedside broad-spectrum use due to their invasiveness, the inconsistent results in demonstrating reproducible outcomes, the requirements of additional trainee personnel and complicated equipment, and the difficult application in awake and non-intubated patients. Recently, ultrasound has been used for the rapid assessment of diaphragm function in acutely ill patients. The advantages of the ultrasound in detecting diaphragm dysfunction as compared with other techniques are the less invasiveness, the avoidance of radiation hazards and the bedside feasibility. Direct imaging of changes in diaphragm thickening (DT) during spontaneous breathing may provide the assessment of both the muscle and the respiratory pump functioning. Indeed, DT has been correlated with the diaphragm strength and the muscle shortening. The volume of diaphragm muscle mass remains constant while it contracts. Consequently, as the muscle shortens it thickens itself and measurements of changes in such a thickening (DT) are inversely related to changes in diaphragm length. Studies in patients with diaphragm paralysis have confirmed the absence of DT. Moreover, since the diaphragm is the major muscle of inspiration, the presence of diaphragm shortening and contraction may predict successful extubation in patients who are invasively ventilated. The aim of the present study is to assess whether DT as measured by ultrasound may predict NIV outcome in patients with de-novo ARF admitted to the Emergency Department (ED).

Conditions

Acute Respiratory Failure

Keywords

Acute Respiratory Failure; Non Invasive Ventilation; Ultrasound; Diaphragm Thickening

Outcome Measures

Primary Outcomes (1)

• Ultrasound Diaphragmayic Thickening to predict NIV outcome in patients with de-novo ARF

  Diaphragm thicknening (DT) will be measured using a 7-10 MHz linear ultrasound probe set to B mode (Vividier, General Electrics). Both the right and left diaphragm will be imaged at the apposition point of the diaphragm and the rib cage on the midaxillary line, between the 8th and the 10th intercostal spaces. DT will be measured at either the end-expiration or the end-inspiration. The percent change in DT between end-expiration and end-inspiration (ΔDT%) will be calculated as \[(DTend-inspiration-DTend-expiration/DTend-expiration)×100\]. The ΔDT% for each patient will represent the mean of three to five breaths. Measurements will be performed by 2 different and appropriately trained operators who are routinely involved in the management of the patients

  96 hours

Secondary Outcomes (1)

• Duration of Mechanical Ventilation (MV) and Emergency Department (ED) stay as well as hospital outcome.

  96 hours for the duration of MV and the ED stay+ 1 year for hospital outcome

Study Arms (1)

Acute Respiratory Failure in NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with de-novo ARF requiring NIV treatment while they will be admitted to the Emergency Department at Gemelli's Hospital, Rome-Italy.

You may qualify if:

• Respiratory rate \> 35 breaths/min,
• PaO2/FiO2 \< 200 while the patient is breathing oxygen through a Venturi mask and active contraction of the accessory muscles of respiration or paradoxical abdominal motion.

You may not qualify if:

• Age \< 18 years,
• Pregnancy,
• Diaphragm paralysis,
• Neuromuscular disorders,
• Palliative NIV in patients with malignancy,
• Ineffective cough,
• Inability to protect airways.
• BMI \> 35

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Intensive Care Unit Policlinico A. Gemelli

Rome, Italy, 00168, Italy

RECRUITING

Related Publications (1)

• Mercurio G, D'Arrigo S, Moroni R, Grieco DL, Menga LS, Romano A, Annetta MG, Bocci MG, Eleuteri D, Bello G, Montini L, Pennisi MA, Conti G, Antonelli M. Diaphragm thickening fraction predicts noninvasive ventilation outcome: a preliminary physiological study. Crit Care. 2021 Jun 26;25(1):219. doi: 10.1186/s13054-021-03638-x.

  PMID: 34174903 DERIVED

Study Officials

• Giovanna Mercurio, MD

  Fondazione Policlinico Agostino Gemelli Rome, Department of Anesthesia and Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Temistocle Taccheri, MD

CONTACT

3470526726; taccheri.temistocle@gmail.com

Simone Carelli, MD

CONTACT

3407465537; simonecarelli.sc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: November 29, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)