{
"info": {
"nct_id": "NCT04074460",
"official_title": "Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study",
"inclusion_criteria": "* Male or female\n* Age 18-80 years\n* Elective surgery\n* Major cancer surgery expecting to last two or more hours, for:\n* Breast (mastectomy or segmentectomy plus sentinel node dissection)\n* Colorectal\n* Lung\n* Prostate\n* Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction\n* Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)\n\nExclusion Criteria\n\n* Palliative surgery for end-stage disease with no curative intent\n* Emergency surgery\n* Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score > 4\n* Age <18 or >80 years old\n* Refusal or inability to provide valid informed consent\n* Risk of severe postoperative nausea and vomiting (PONV risk score >3)\n* Previous allergy or contraindication to either anaesthetic medication\n* Indication for gas induction of anaesthesia\n* Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Male or female",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
}
]
},
{
"line": "* Age 18-80 years",
"criterions": [
{
"exact_snippets": "Age 18-80 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Elective surgery",
"criterions": [
{
"exact_snippets": "Elective surgery",
"criterion": "elective surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Major cancer surgery expecting to last two or more hours, for:",
"criterions": [
{
"exact_snippets": "Major cancer surgery expecting to last two or more hours",
"criterion": "cancer surgery duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "hours"
}
}
]
}
]
},
{
"line": "* Breast (mastectomy or segmentectomy plus sentinel node dissection)",
"criterions": [
{
"exact_snippets": "Breast (mastectomy or segmentectomy plus sentinel node dissection)",
"criterion": "breast surgery",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"mastectomy",
"segmentectomy"
]
}
]
},
{
"exact_snippets": "Breast (mastectomy or segmentectomy plus sentinel node dissection)",
"criterion": "sentinel node dissection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Colorectal",
"criterions": [
{
"exact_snippets": "Colorectal",
"criterion": "colorectal cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Lung",
"criterions": [
{
"exact_snippets": "Lung",
"criterion": "lung",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Prostate",
"criterions": [
{
"exact_snippets": "Prostate",
"criterion": "prostate",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction",
"criterions": [
{
"exact_snippets": "Melanoma",
"criterion": "melanoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "excision of melanoma",
"criterion": "melanoma excision",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": true
}
]
},
{
"exact_snippets": "lymph node dissection",
"criterion": "lymph node dissection",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": true
}
]
},
{
"exact_snippets": "skin flap construction",
"criterion": "skin flap construction",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": true
}
]
}
]
},
{
"line": "* Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)",
"criterions": [
{
"exact_snippets": "Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)",
"criterion": "major cancer surgeries",
"requirements": [
{
"requirement_type": "examples",
"expected_value": [
"oesophagectomy",
"head and neck cancer"
]
}
]
}
]
},
{
"line": "* Palliative surgery for end-stage disease with no curative intent",
"criterions": [
{
"exact_snippets": "Palliative surgery",
"criterion": "surgery type",
"requirements": [
{
"requirement_type": "intent",
"expected_value": "palliative"
}
]
},
{
"exact_snippets": "end-stage disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "end-stage"
}
]
},
{
"exact_snippets": "no curative intent",
"criterion": "treatment intent",
"requirements": [
{
"requirement_type": "intent",
"expected_value": "non-curative"
}
]
}
]
},
{
"line": "* Emergency surgery",
"criterions": [
{
"exact_snippets": "Emergency surgery",
"criterion": "emergency surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score > 4",
"criterions": [
{
"exact_snippets": "Extensive comorbid disease",
"criterion": "comorbid disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "extensive"
}
]
},
{
"exact_snippets": "American Society of Anesthesiologists (ASA) Score > 4",
"criterion": "ASA Score",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Age <18 or >80 years old",
"criterions": [
{
"exact_snippets": "Age <18 or >80 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
},
{
"operator": ">",
"value": 80,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Refusal or inability to provide valid informed consent",
"criterions": [
{
"exact_snippets": "Refusal ... to provide valid informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "inability to provide valid informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Risk of severe postoperative nausea and vomiting (PONV risk score >3)",
"criterions": [
{
"exact_snippets": "Risk of severe postoperative nausea and vomiting (PONV risk score >3)",
"criterion": "PONV risk score",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Previous allergy or contraindication to either anaesthetic medication",
"criterions": [
{
"exact_snippets": "Previous allergy ... to either anaesthetic medication",
"criterion": "allergy to anaesthetic medication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "contraindication to either anaesthetic medication",
"criterion": "contraindication to anaesthetic medication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Indication for gas induction of anaesthesia",
"criterions": [
{
"exact_snippets": "Indication for gas induction of anaesthesia",
"criterion": "indication for gas induction of anaesthesia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.",
"criterions": [
{
"exact_snippets": "Currently enrolled in another clinical trial",
"criterion": "enrollment in another clinical trial",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "Exclusion Criteria",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}