Postoperative Pulmonary Complications (PPCs)
Conditions
Keywords
HFNO, High flow nasal oxygen, Postoperative pulmonary complication
Brief summary
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.
Interventions
COMBINATION_PRODUCTHigh Flow Oxygen
High flow nasal oxygen will be administered in the intervention group
COMBINATION_PRODUCTOxygen
Oxygen delivered by nasal cannula or oxymask
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Age \> 65 years * BMI \>30 * Preoperative SpO2 \<95 % * Scheduled for lobectomy or pulmonary segment resection * Respiratory tract infection the last month * Preoperative anaemia (Hb \<100) or severe hypoalbuminemia (\<20 g/L) * Current smoker or previous smoker with \>30 packyears * Pulmonary disease or OSAS * Heart failure * Clinical frailty (CFS 4)
Exclusion criteria
* Not suitable for postoperative HFNO, as decided by a study member or the anaesthetist in charge (such as total nasal obstruction, skull fracture, facial injuries) * Pregnancy * Not able to understand the study information or sign an informed consent. * Not able to participate with the treatment postoperatively * Planned for delayed extubation in the intensive care * Preoperative non-invasive ventilation due to respiratory failure or a higher level of care than a regular ward
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality in hospital | Up until 30 days after surgery | Mortality during hospital admission after surgery |
| 30-days mortality | 30 days after surgery | 30-days mortality, number and proportion of patients between the groups |
| Healthy days at home 30 days after surgery | 30 days postoperatively | Number of healthy days at home 30 days after surgery compared between the groups |
| Lowest SpO2 the first 2 and 24 h after randomisation | 24 hours after randomisation | Lowest oxygen saturation registered in the chart during the first 2 and 24 h after randomisation |
| Desaturation (SpO2 <90%) the first 2 or 4 and under 24 hours after randomisation | First 24 hours after randomisation | Proportion of patients that has a registered oxygen saturation under 90% 2, 4 and 24 hours after randomisation |
| Lowest PaO2/FiO2 ratio during the intervention period | Maximum 4 hours after start of intervention postoperatively | 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) |
| Subjective patient comfort (visual scale 0-10) | Maximum 4 hours after start of intervention | Patients will report their comfort with each method, HFNO or COT after the intervention |
| Length of stay in hospital | From surgery up until 30 days after surgery | The length of stay in hospital after surgery will be recorded and compared |
| Length of stay (LOS) in the postoperative unit | Up to 7 days after surgery | The duration of stay in the postoperative unit will be registered and compared between the groups |
Countries
Sweden
Contacts
CONTACTIda-Maria Forsberg, PhD
Outcome results
None listed