Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)DiaDeaNCT03314883
Diaphragmatic Ultrasound in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)
A study testing D-US ARF in people with Acute Hypoxic - Hypercapnic Respiratory Failure (ARF), run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)
- What is being tested?
- D-US ARF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2017to 4 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- respiratory failure resulting in respiratory acidosis to be treated with NIV
- Age> = 18 years
Who cannot join
- acute pulmonary edema
- coexisting interstitial pathologies
- neuromuscular pathologies
- thoracic cage's deformity
- previous diaphragmatic paralysis
- hemodynamic instability
Show all 12Show fewer
- intracranial hypertension
- pregnancy
- absolute contraindications to NIV
- need for immediate intubation,
- recent thoracotomy
- presence of pneumothorax or pneumomediastinum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Diaphragmatic Evaluation in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF) Patients Undergoing Non Invasive Ventilation: A Pilot Feasibility Study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- D-US ARF
- Keywords
- Ultrasound, Diaphragm, Non Invasive Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-US ARFDiagnostic test
Diaphragm ultrasound evaluation in acute hypoxic - hypercapnic respiratory failure (ARF) patients undergoing non invasive ventilation, with regard to thickening (%) and excursion (millimeters)
| Study group | Role | What they receive |
|---|---|---|
| D-US ARF | Experimental | Diaphragmatic evaluation, i.e thickening fraction (%) and excursion (millimeters), will be performed 3 times in the first two hours after acute hypoxic - hypercapnic respiratory failure (ARF) patients admission Receives: Diagnostic Test: D-US ARF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Ultrasound will be performed before starting NIV, after 1 and 2 two hours of NIV application
Measured: 2 hours
Secondary outcomes (14)
Arterial blood carbon dioxide (PaCO2) compensation evaluation
PaCO2 at time of starting NIV, after one hour from NIV application and after two hours of NIV application
Measured: 0 hour
Arterial blood carbon dioxide (PaCO2) compensation evaluation
PaCO2 at time of starting NIV, after one hour from NIV application
Measured: 1 hour
Arterial blood carbon dioxide (PaCO2) compensation evaluation
PaCO2 after two hours from NIV application
Measured: 2 hours
Monitoring diaphragmatic function in terms of thickening at 0 hour
Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100
Measured: 0 hour
Monitoring diaphragmatic function in terms of thickening at 1 hour
Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100
Measured: 1 hour
Monitoring diaphragmatic function in terms of thickening at 2 hours
Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100
Measured: 2 hours
Monitoring diaphragmatic function in terms of excursion at 0 hour
Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath
Measured: 0 hour
Monitoring diaphragmatic function in terms of excursion at 1 hour
Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath
Measured: 1 hour
Monitoring diaphragmatic function in terms of excursion at 2 hours
Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath
Measured: 2 hours
Days spent in intensive care unit
Amount of days spent in ICU
Measured: 28 days
Days spent in in hospital
Amount of days spent in hospital
Measured: 90 days
dyspnea level at 0 hour
dyspnea level evaluated via visual analogical scale
Measured: 0 hour
dyspnea level at 1 hour
dyspnea level evaluated via visual analogical scale
Measured: 1 hour
dyspnea level at 2 hours
dyspnea level evaluated via visual analogical scale
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start9 Oct 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314883
- Sponsor's protocol ID
- CE 112/17
- Acronym
- DiaDea
- Status last verified
- May 2018
- First submitted
- 22 Sep 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cammarota G, Sguazzotti I, Zanoni M, Messina A, Colombo D, Vignazia GL, Vetrugno L, Garofalo E, Bruni A, Navalesi P, Avanzi GC, Della Corte F, Volpicelli G, Vaschetto R. Diaphragmatic Ultrasound Assessment in Subjects With Acute Hypercapnic Respiratory Failure Admitted to the Emergency Department. Respir Care. 2019 Dec;64(12):1469-1477. doi: 10.4187/respcare.06803. Epub 2019 Aug 27.
PubMed 31455684
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Diaphragmatic Evaluation in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF) Patients Undergoing Non Invasive Ventilation: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT03314883
- Acronym / sponsor ID
- DiaDea / CE 112/17
- Keywords
- Ultrasound, Diaphragm, Non Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-US ARF | Experimental | Diagnostic Test: D-US ARFDiaphragmatic evaluation, i.e thickening fraction (%) and excursion (millimeters), will be performed 3 times in the first two hours after acute hypoxic - hypercapnic respiratory failure (ARF) patients admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- respiratory failure resulting in respiratory acidosis to be treated with NIV
- Age> = 18 years
Key exclusion criteria (12 listed)
- acute pulmonary edema
- coexisting interstitial pathologies
- neuromuscular pathologies
- thoracic cage's deformity
- previous diaphragmatic paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-US ARFDiaphragm ultrasound evaluation in acute hypoxic - hypercapnic respiratory failure (ARF) patients undergoing non invasive ventilation, with regard to thickening (%) and excursion (millimeters) | Diagnostic test | D-US ARF |
Primary outcome
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
14 secondary outcomes
Arterial blood carbon dioxide (PaCO2) compensation evaluation
Time frame: 0 hour
Arterial blood carbon dioxide (PaCO2) compensation evaluation
Time frame: 1 hour
Arterial blood carbon dioxide (PaCO2) compensation evaluation
Time frame: 2 hours
Monitoring diaphragmatic function in terms of thickening at 0 hour
Time frame: 0 hour
Monitoring diaphragmatic function in terms of thickening at 1 hour
Time frame: 1 hour
Monitoring diaphragmatic function in terms of thickening at 2 hours
Time frame: 2 hours
Monitoring diaphragmatic function in terms of excursion at 0 hour
Time frame: 0 hour
Monitoring diaphragmatic function in terms of excursion at 1 hour
Time frame: 1 hour
Monitoring diaphragmatic function in terms of excursion at 2 hours
Time frame: 2 hours
Days spent in intensive care unit
Time frame: 28 days
Days spent in in hospital
Time frame: 90 days
dyspnea level at 0 hour
Time frame: 0 hour
dyspnea level at 1 hour
Time frame: 1 hour
dyspnea level at 2 hours
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Derived from this study: PubMed 31455684Cammarota G, Sguazzotti I, Zanoni M, Messina A, Colombo D, Vignazia GL, Vetrugno L, Garofalo E, Bruni A, Navalesi P, Avanzi GC, Della Corte F, Volpicelli G, Vaschetto R. Diaphragmatic Ultrasound Assessment in Subjects With Acute Hypercapnic Respiratory Failure Admitted to the Emergency Department. Respir Care. 2019 Dec;64(12):1469-1477. doi: 10.4187/respcare.06803. Epub 2019 Aug 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-US ARF in people with Acute Hypoxic - Hypercapnic Respiratory Failure (ARF), run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.