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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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High flow nasal oxygen (HFNO) in the immediate postoperative period has been demonstrated to reduce the risk of postoperative pulmonary complications (PPC) after cardiothoracic surgery. In specific groups of patients such as the obese and after upper abdominal surgery the results are contradictive. However, there is lack of evidence if HFNO in the general high-risk patient after abdominal and non-cardiac thoracic surgery can reduce the prevalence of PPC, hypoxaemia and escalation of therapy. Therefore, the investigators aim to compare the use of HFNO with conventional oxygen therapy (COT) in high-risk patients after abdominal and non-cardiac thoracic surgery regarding postoperative pulmonary complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNO | Experimental | Group of patients receiving HFNO postoperatively |
|
| Conventional oxygen therapy (COT) | Active Comparator | Group of patients receiving conventional oxygen therapy postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Oxygen | Combination Product | High flow nasal oxygen will be administered in the intervention group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of postoperative pulmonary complications (PPC) the first seven days after high-risk abdominal or non-cardiac thoracic surgery in high-risk patients with high-flow nasal oxygen or conventional oxygen therapy in the immediate postoperative period | Up to 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest SpO2 the first 2 and 24 h after randomisation | Lowest oxygen saturation registered in the chart during the first 2 and 24 h after randomisation | 24 hours after randomisation |
| Desaturation (SpO2 <90%) the first 2 or 4 and under 24 hours after randomisation |
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Inclusion Criteria:
Adults (≥18 years old) scheduled for elective abdominal (laparotomy or laparoscopy), open abdominal vascular or non-cardiac thoracic surgery under general anaesthesia with an estimated duration over 3 hours.
AND
Meeting at least two of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ida-Maria Forsberg, PhD | Contact | +46704381445 | ida-maria.forsberg@regionstockholm.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Oxygen | Combination Product | Oxygen delivered by nasal cannula or oxymask |
|
Proportion of patients that has a registered oxygen saturation under 90% 2, 4 and 24 hours after randomisation |
| First 24 hours after randomisation |
| Lowest PaO2/FiO2 ratio during the intervention period | Comparison of the lowest PaO2 and FiO2 (fraction of inspired oxygen) during the intervention period ( i e 2 or 4 hours depending of the result from the air test) | Maximum 4 hours after start of intervention postoperatively |
| Subjective patient comfort (visual scale 0-10) | Patients will report their comfort with each method, HFNO or COT after the intervention | Maximum 4 hours after start of intervention |
| Length of stay (LOS) in the postoperative unit | The duration of stay in the postoperative unit will be registered and compared between the groups | Up to 7 days after surgery |
| Length of stay in hospital | The length of stay in hospital after surgery will be recorded and compared | From surgery up until 30 days after surgery |
| Mortality in hospital | Mortality during hospital admission after surgery | Up until 30 days after surgery |
| 30-days mortality | 30-days mortality, number and proportion of patients between the groups | 30 days after surgery |
| Healthy days at home 30 days after surgery | Number of healthy days at home 30 days after surgery compared between the groups | 30 days postoperatively |