{
"info": {
"nct_id": "NCT03133520",
"official_title": "Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure",
"inclusion_criteria": "* Known immunosuppression defined as haematological malignancy.\n* Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2<92%\n* Respiratory distress with a respiratory rate >22/min\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Refusal of study participation\n* Pregnancy or breastfeeding\n* Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg)\n* Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation)\n* Haemodynamic instability (mean arterial pressure <65 mmHg)\n* Vasopressor needs\n* Awareness confusion and disorientation",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Known immunosuppression defined as haematological malignancy.",
"criterions": [
{
"exact_snippets": "Known immunosuppression defined as haematological malignancy.",
"criterion": "immunosuppression",
"requirement": {
"requirement_type": "definition",
"expected_value": "haematological malignancy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Known immunosuppression defined as haematological malignancy.",
"criterion": "immunosuppression",
"requirement": {
"requirement_type": "definition",
"expected_value": "haematological malignancy"
}
}
]
}
},
{
"identified_line": {
"line": "* Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2<92%",
"criterions": [
{
"exact_snippets": "Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg",
"criterion": "PaO2/FiO2",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 300,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: ... (b) PaCO2≤45 mmHg",
"criterion": "PaCO2",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 45,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: ... (c) SaO2<92%",
"criterion": "SaO2",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 92,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg",
"criterion": "PaO2/FiO2",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 300,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: ... (b) PaCO2≤45 mmHg",
"criterion": "PaCO2",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 45,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: ... (c) SaO2<92%",
"criterion": "SaO2",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 92,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Respiratory distress with a respiratory rate >22/min",
"criterions": [
{
"exact_snippets": "Respiratory distress",
"criterion": "respiratory distress",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "respiratory rate >22/min",
"criterion": "respiratory rate",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": ">",
"value": 22,
"unit": "min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Respiratory distress",
"criterion": "respiratory distress",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "respiratory rate >22/min",
"criterion": "respiratory rate",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": ">",
"value": 22,
"unit": "min"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Refusal of study participation",
"criterions": [
{
"exact_snippets": "Refusal of study participation",
"criterion": "study participation",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Refusal of study participation",
"criterion": "study participation",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Pregnancy or breastfeeding",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg)",
"criterions": [
{
"exact_snippets": "Hypercapnia",
"criterion": "hypercapnia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "formal indication for non-invasive mechanical ventilation (NIMV)",
"criterion": "indication for non-invasive mechanical ventilation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "PaCO2 ≥ 45 mmHg",
"criterion": "PaCO2 level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 45,
"unit": "mmHg"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Hypercapnia",
"criterion": "hypercapnia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "formal indication for non-invasive mechanical ventilation (NIMV)",
"criterion": "indication for non-invasive mechanical ventilation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "PaCO2 ≥ 45 mmHg",
"criterion": "PaCO2 level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 45,
"unit": "mmHg"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation)",
"criterions": [
{
"exact_snippets": "clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation)",
"criterion": "NIMV (Non-Invasive Mechanical Ventilation)",
"requirement": {
"requirement_type": "decision",
"expected_value": true
}
},
{
"exact_snippets": "clinicians have decided on ... IMV (Invasive Mechanical Ventilation)",
"criterion": "IMV (Invasive Mechanical Ventilation)",
"requirement": {
"requirement_type": "decision",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation)",
"criterion": "NIMV (Non-Invasive Mechanical Ventilation)",
"requirement": {
"requirement_type": "decision",
"expected_value": true
}
},
{
"exact_snippets": "clinicians have decided on ... IMV (Invasive Mechanical Ventilation)",
"criterion": "IMV (Invasive Mechanical Ventilation)",
"requirement": {
"requirement_type": "decision",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Haemodynamic instability (mean arterial pressure <65 mmHg)",
"criterions": [
{
"exact_snippets": "Haemodynamic instability (mean arterial pressure <65 mmHg)",
"criterion": "haemodynamic instability",
"requirement": {
"requirement_type": "mean arterial pressure",
"expected_value": {
"operator": "<",
"value": 65,
"unit": "mmHg"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Haemodynamic instability (mean arterial pressure <65 mmHg)",
"criterion": "haemodynamic instability",
"requirement": {
"requirement_type": "mean arterial pressure",
"expected_value": {
"operator": "<",
"value": 65,
"unit": "mmHg"
}
}
}
}
},
{
"identified_line": {
"line": "* Vasopressor needs",
"criterions": [
{
"exact_snippets": "Vasopressor needs",
"criterion": "vasopressor needs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Vasopressor needs",
"criterion": "vasopressor needs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Awareness confusion and disorientation",
"criterions": [
{
"exact_snippets": "Awareness confusion",
"criterion": "awareness",
"requirement": {
"requirement_type": "state",
"expected_value": "confusion"
}
},
{
"exact_snippets": "disorientation",
"criterion": "orientation",
"requirement": {
"requirement_type": "state",
"expected_value": "disorientation"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Awareness confusion",
"criterion": "awareness",
"requirement": {
"requirement_type": "state",
"expected_value": "confusion"
}
},
{
"exact_snippets": "disorientation",
"criterion": "orientation",
"requirement": {
"requirement_type": "state",
"expected_value": "disorientation"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}