Postoperative High-flow Nasal Oxygenation After High-risk Surgery in the Frail Adult

N/ANot Yet RecruitingNCT07464730

Region Stockholm200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Postoperative Pulmonary Complications (PPCs)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Up to 7 days after surgery

Secondary Outcomes

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

Time frame: 24 hours after randomisation

Desaturation (SpO2 <90%) the first 2 or 4 and under 24 hours after randomisation

Proportion of patients that has a registered oxygen saturation under 90% 2, 4 and 24 hours after randomisation

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Up to 7 days after surgery

Length of stay in hospital

The length of stay in hospital after surgery will be recorded and compared

Time frame: From surgery up until 30 days after surgery

Mortality in hospital

Mortality during hospital admission after surgery

Time frame: Up until 30 days after surgery

30-days mortality

30-days mortality, number and proportion of patients between the groups

Time frame: 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

Time frame: 30 days postoperatively