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Diaphragm Ultrasound as a Powerful Tool in Managing Acute Hypoxemic Respiratory Failure in Hematological Patients
| Condition or disease |
|---|
| Respiratory Failure Diaphragm Injury Ultrasound Mechanical Ventilation Complication |
Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. In these cohort of patients mechanical ventilation is frequently needed in order to restore oxygenation and normocapnia. Since every positive-pressure ventilation regimen may potentially determine pulmonary complications, due to alteration in pressure and volume lung homeostasis and diaphragm activity, also diaphragm function has to be assessed not to worsen ventilator-induced lung injury (VILI). Main targets of VILI are pulmonary interstitium and diaphragm.
Pulmonary interstitium is frequently involved in different mechanism of injury, that derive both from induced tidal volume and positive end expiratory pressure (PEEP). Indeed, large tidal volumes generated during assisted spontaneous breathing may configure non-protective ventilation regimens and the so called "pendelluft phenomenon", that is the intrinsic flow of air within the lung from nondependent to dependent regions without changes in tidal volume, may affect inadequate PEEP values.
Positive-pressure ventilation may also alter diaphragm activity. Recent data show that diaphragm disfunction, considered as an enhanced or reduced thickening fraction, occurs in about 65% of patients undergoing mechanical ventilation.
Since the potential harm of positive-pressure ventilation, the optimization of mechanical ventilation is pivotal to ensure an adequate time-to-recovery without concurring to the onset of further lung and diaphragmatic injury. Neurally Adjusted Ventilatory Assist (NAVA) is a recent modality of mechanical ventilation that delivers ventilatory assistance according to the respiratory effort of the patient, measured by electrical activity of the diaphragm (EAdi). NAVA works proportionally with EAdi values, ensuring a better neuroventilatory efficiency compared to other mechanical ventilation modes and also reducing patient-ventilator asynchrony. According to these features NAVA protocol may be useful in preserving gas exchanges and diaphragm function both in invasive and non-invasive ventilation.
Therefore the evaluation of basal diaphragm activity, the choice of the device for oxygen support administration and the setting of ventilatory parameters may influence hospital stay and outcome of patients affected by acute hypoxemic respiratory failure.
The aim of this study is to evaluate the basal diaphragm activity of acute hypoxemic respiratory failure patients admitted in Intensive Care Unit (ICU) and to record diaphragm activity modifications during the ICU stay in relation to the optimization of medical therapy and, if necessary, according to the need of ventilatory support (invasive or non-invasive ventilation delivered with NAVA protocol).
This study intends to register also daily diaphragm thickening fraction, daily arterial blood gas analysis, failure frequency of non-invasive ventilation, frequency of tracheal intubation, length of mechanical ventilation, length of hospital stay and hospital mortality.
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Diaphragmatic Function in Hematological Patients With Acute Hypoxemic Respiratory Failure |
| Actual Study Start Date : | May 27, 2019 |
| Estimated Primary Completion Date : | May 27, 2022 |
| Estimated Study Completion Date : | May 27, 2022 |
- Diaphragm thickening fraction [ Time Frame: At ICU admission ]Diaphragm thickening fraction measured with echography
- Diaphragm thickening fraction [ Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months ]Diaphragm thickening fraction measured with echography
- Arterial blood gas analysis [ Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months ]Arterial blood gas analysis
- Failure of non-invasive ventilation [ Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months ]Failure of non-invasive ventilation according to hospital NIV protocol
- Rate of tracheal intubation [ Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months ]Tracheal intubation
- Duration of positive-pressure ventilation [ Time Frame: From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months ]Duration of positive-pressure ventilation (NIV or mechanical ventilation)
- Hospital length of stay [ Time Frame: From date of in-hospital admission until the date of hospital discharge, assessed up to 36 months ]Hospital length of stay
- In-hospital mortality [ Time Frame: From date of in-hospital admission until the date of death from any cause or hospital discharge, assessed up to 36 months ]In-hospital mortality
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Hypoxemic respiratory failure in hematological patients (PaO2 < 70 mmHg or P/F < 150)
Exclusion Criteria:
- Patients with positive-pressure ventilation regimen of high flow nasal cannula prior to ICU admission
- Unstable clinical condition (use of vasopressors, acute coronary syndrome...)
- Refusal of treatment or informed consent
- Agitation (RASS ≥+2) or lack of collaboration (Kelly Matthay ≥ 5)
- Multiple organ failure
- Enrollment in other study protocols
| Contact: Luigi Vetrugno, Doctor | +393382873386 | luigi.vetrugno@asuiud.sanita.fvg.it | |
| Contact: Tiziana Bove, Professor | +393474785763 | tiziana.bove@asuiud.sanita.fvg.it |
| Italy | |
| Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD | Recruiting |
| Udine, Italy, 33100 | |
| Contact: Luigi Vetrugno, Doctor +393382873386 luigi.vetrugno@asuiud.sanita.fvg.it | |
| Contact: Tiziana Bove, Professor +393474785763 tiziana.bove@asuiud.sanita.fvg.it | |
| Principal Investigator: | Luigi Vetrugno, Doctor | Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 15, 2019 | ||||||||
| First Posted Date | July 19, 2019 | ||||||||
| Last Update Posted Date | October 8, 2020 | ||||||||
| Actual Study Start Date | May 27, 2019 | ||||||||
| Estimated Primary Completion Date | May 27, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Diaphragm thickening fraction [ Time Frame: At ICU admission ] Diaphragm thickening fraction measured with echography
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Diaphragm Ultrasound as a Powerful Tool in Managing Acute Hypoxemic Respiratory Failure in Hematological Patients | ||||||||
| Official Title | Evaluation of Diaphragmatic Function in Hematological Patients With Acute Hypoxemic Respiratory Failure | ||||||||
| Brief Summary | Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. Mechanical ventilation is frequently needed and diaphragm activity has to be assessed not to worsen ventilator-induced lung injury. | ||||||||
| Detailed Description |
Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. In these cohort of patients mechanical ventilation is frequently needed in order to restore oxygenation and normocapnia. Since every positive-pressure ventilation regimen may potentially determine pulmonary complications, due to alteration in pressure and volume lung homeostasis and diaphragm activity, also diaphragm function has to be assessed not to worsen ventilator-induced lung injury (VILI). Main targets of VILI are pulmonary interstitium and diaphragm. Pulmonary interstitium is frequently involved in different mechanism of injury, that derive both from induced tidal volume and positive end expiratory pressure (PEEP). Indeed, large tidal volumes generated during assisted spontaneous breathing may configure non-protective ventilation regimens and the so called "pendelluft phenomenon", that is the intrinsic flow of air within the lung from nondependent to dependent regions without changes in tidal volume, may affect inadequate PEEP values. Positive-pressure ventilation may also alter diaphragm activity. Recent data show that diaphragm disfunction, considered as an enhanced or reduced thickening fraction, occurs in about 65% of patients undergoing mechanical ventilation. Since the potential harm of positive-pressure ventilation, the optimization of mechanical ventilation is pivotal to ensure an adequate time-to-recovery without concurring to the onset of further lung and diaphragmatic injury. Neurally Adjusted Ventilatory Assist (NAVA) is a recent modality of mechanical ventilation that delivers ventilatory assistance according to the respiratory effort of the patient, measured by electrical activity of the diaphragm (EAdi). NAVA works proportionally with EAdi values, ensuring a better neuroventilatory efficiency compared to other mechanical ventilation modes and also reducing patient-ventilator asynchrony. According to these features NAVA protocol may be useful in preserving gas exchanges and diaphragm function both in invasive and non-invasive ventilation. Therefore the evaluation of basal diaphragm activity, the choice of the device for oxygen support administration and the setting of ventilatory parameters may influence hospital stay and outcome of patients affected by acute hypoxemic respiratory failure. The aim of this study is to evaluate the basal diaphragm activity of acute hypoxemic respiratory failure patients admitted in Intensive Care Unit (ICU) and to record diaphragm activity modifications during the ICU stay in relation to the optimization of medical therapy and, if necessary, according to the need of ventilatory support (invasive or non-invasive ventilation delivered with NAVA protocol). This study intends to register also daily diaphragm thickening fraction, daily arterial blood gas analysis, failure frequency of non-invasive ventilation, frequency of tracheal intubation, length of mechanical ventilation, length of hospital stay and hospital mortality. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Hematologic patients with hypoxemic respiratory failure | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
30 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 27, 2022 | ||||||||
| Estimated Primary Completion Date | May 27, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Italy | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04026217 | ||||||||
| Other Study ID Numbers | 2745 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement |
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| Responsible Party | Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine | ||||||||
| Study Sponsor | Azienda Sanitaria-Universitaria Integrata di Udine | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Azienda Sanitaria-Universitaria Integrata di Udine | ||||||||
| Verification Date | October 2020 | ||||||||
