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Completed

NCT Number: NCT03314883

Diaphragmatic Ultrasound in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)

Mortality of acute hypoxic - hypercapnic respiratory failure (ARF) patients underwent invasive mechanical ventilation is demonstrated to be higher than in patients who underwent only non invasive mechanical ventilation (NIV).

There is an increased need to detect more predictive factors for NIV failure, in order to better identify patients most at risk of facing negative outcomes.

The aim of this experimental pilot study is to evaluate the feasibility of the ultrasound of diaphragm in ARF patients underwent non invasive mechanical ventilation ( primary endpoint ).

Furthermore the secondary aim is to observe any relationship between diaphragmatic function (excursion), diaphragmatic thickening and the timing of arterial blood gases (ABGs) compensation in patients with ARF undergoing NIV treatment; additional outcomes are: correlation with dyspnea level, time of mechanical ventilation, NIV failure, rate of tracheostomy, length of stay in ICU and in-hospital and 90-day mortality.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.O.U Maggiore della Carità

Novara, 28100, Italy

About this study

Inclusion criteria

respiratory failure resulting in respiratory acidosis to be treated with NIV, age> = 18 years

Exclusion criteria

acute pulmonary edema, coexisting interstitial pathologies, neuromuscular pathologies, thoracic cage's deformity, previous diaphragmatic paralysis, hemodynamic instability, intracranial hypertension, pregnancy, absolute contraindications to NIV, need for immediate intubation, recent thoracotomy, presence of pneumothorax or pneumomediastinum.

After patient's triage, transfer to Shock Room and primary assessment by emergency department staff ,diaphragmatic ultrasound is performed when NIV indication is given.

NIV is delivered with a facial mask; ventilation is set in NIV application, pressure support mode. Positive end expiratory pressure (PEEP) and Inspired oxygen fraction (FiO2) are adjusted to obtain a peripheral oxygen saturation (Spo2) between 88-92%. The pressure support is set to achieve a target volume of between 6-8 (ml / kg) and a respiratory rate < 30 respiratory acts per minute.

Respectively one and two hours after starting NIV, diaphragmatic ultrasonography and ABGs analysis are again performed.

NIV failure criteria are defined by the need for endotracheal intubation or by death.

Criteria for NIV failure: unchanging or worsening blood gases despite NIV; need to protect airways due to neurological deterioration or massive secretions; haemodynamic instability or major electrocardiographic abnormalities; uncontrolled dyspnea and NIV intolerance/ refusal.

General measures On admission clinical severity is recorded by Glasgow Coma Scale (GCS), Acute Physiology and Chronic Health Evaluation II Score (APACHE II).

ABGs values ( PH, arterial oxygen tension (paO2), arterial carbon dioxide tension (paCo2), paO2/FiO2, bicarbonates (HCO3), lactate) will be recorded before NIV, at 1 hour and 2 hours later.

Chest X-ray and peripheral blood sample (hemochrome with band cell count, C-reactive protein (CRP) and electrolytes) will be performed within 24 hours of admission.

The presence of pneumonia, sepsis and previous treatment with systemic or inhaled steroids will be recorded.

Diaphragm Ultrasound

Ultrasound evaluation of diaphragm function is performed on admission before starting NIV, 1 hour and 2 hours later.

Diaphragmatic function is assessed by a B-Mode ultrasound device connected to a linear probe ( 7-12 MHz) at the patient's bedside.

Measurements are performed on a patient in supine position with a recessed back angle between 20 and 40 degrees.

Probe position is set between 8th and 10th intercostal space on the mid axillary line to find the apposition zone of the diaphragm, where lung, diaphragm and abdominal parenchyma are identifiable.

Diaphragmatic thickness is measured at end-inspiration ( Ti) and end- expiration (Te).

The percentage change in diaphragmatic thickness (ΔTdi) is calculated as follows:

ΔTdi % = (Ti- Te) / Te * 100 Measurements are performed three times and the average value of the three measurements is considered.

Diaphragmatic excursion is also evaluated.

Statistical analysis As it is an experimental pilot feasibility study, 20 patients will be initially enrolled.

Descriptive statistics for continuous variables will be presented as median and interquartile. Non-parametric continuous variables will be evaluated by non-parametric Wilcoxon test (Mann-Whitney).

Categorical variables will be evaluated by chi-square or Fisher's test.

The influence of diaphragmatic thickening and muscle thickness on NIV failure, mortality and hospitalization's days wil be assessed through correlation analysis A P-value <0.05 will be considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • respiratory failure resulting in respiratory acidosis to be treated with NIV
  • Age> = 18 years

Exclusion criteria

  • acute pulmonary edema
  • coexisting interstitial pathologies
  • neuromuscular pathologies
  • thoracic cage's deformity
  • previous diaphragmatic paralysis
  • hemodynamic instability
  • intracranial hypertension
  • pregnancy
  • absolute contraindications to NIV
  • need for immediate intubation,
  • recent thoracotomy
  • presence of pneumothorax or pneumomediastinum

Treatment and study plan

D-US ARF

Diagnostic Test

Diaphragm ultrasound evaluation in acute hypoxic - hypercapnic respiratory failure (ARF) patients undergoing non invasive ventilation, with regard to thickening (%) and excursion (millimeters)

Primary outcomes

  1. Feasibility of diaphragm ultrasound function evaluation (excursion and thickening) in acute hypoxic - hypercapnic respiratory failure (ARF) during the first two hours after emergency department admission.

    Time frame: 2 hours

    Ultrasound will be performed before starting NIV, after 1 and 2 two hours of NIV application

Secondary outcomes

  1. Arterial blood carbon dioxide (PaCO2) compensation evaluation

    Time frame: 0 hour

    PaCO2 at time of starting NIV, after one hour from NIV application and after two hours of NIV application

  2. Arterial blood carbon dioxide (PaCO2) compensation evaluation

    Time frame: 1 hour

    PaCO2 at time of starting NIV, after one hour from NIV application

  3. Arterial blood carbon dioxide (PaCO2) compensation evaluation

    Time frame: 2 hours

    PaCO2 after two hours from NIV application

  4. Monitoring diaphragmatic function in terms of thickening at 0 hour

    Time frame: 0 hour

    Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100

  5. Monitoring diaphragmatic function in terms of thickening at 1 hour

    Time frame: 1 hour

    Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100

  6. Monitoring diaphragmatic function in terms of thickening at 2 hours

    Time frame: 2 hours

    Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100

  7. Monitoring diaphragmatic function in terms of excursion at 0 hour

    Time frame: 0 hour

    Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath

  8. Monitoring diaphragmatic function in terms of excursion at 1 hour

    Time frame: 1 hour

    Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath

  9. Monitoring diaphragmatic function in terms of excursion at 2 hours

    Time frame: 2 hours

    Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath

  10. Days spent in intensive care unit

    Time frame: 28 days

    Amount of days spent in ICU

  11. Days spent in in hospital

    Time frame: 90 days

    Amount of days spent in hospital

  12. dyspnea level at 0 hour

    Time frame: 0 hour

    dyspnea level evaluated via visual analogical scale

  13. dyspnea level at 1 hour

    Time frame: 1 hour

    dyspnea level evaluated via visual analogical scale

  14. dyspnea level at 2 hours

    Time frame: 2 hours

    dyspnea level evaluated via visual analogical scale

Other outcomes

  1. Relationship with mechanical ventilation length

    Time frame: 28 days

    mechanical ventilation length expressed in days for both invasive and non invasive ventilation

  2. Mortality in intensive care unit

    Time frame: 28 days

    Number of death in intensive care unit

  3. Tracheostomy

    Time frame: 28 days

    Rate of tracheostomy (ratio between number of tracheostomy in study group)

  4. Relation with gravity index

    Time frame: 24 hours

    value of APACHE score in study population

  5. Mortality in hospital

    Time frame: 90 days

    Number of death in hospital

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Official study title

Ultrasound Diaphragmatic Evaluation in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF) Patients Undergoing Non Invasive Ventilation: A Pilot Feasibility Study

Acronym: DiaDea

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2017
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.