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Recruiting NCT07464730

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

No phase Interventional Postoperative Pulmonary Complications (PPCs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Flow Oxygen, Oxygen.
Who it may be relevant to
Registry conditions: Postoperative Pulmonary Complications (PPCs). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Interventions

  • Combination product High Flow Oxygen
    High flow nasal oxygen will be administered in the intervention group
  • Combination product Oxygen
    Oxygen delivered by nasal cannula or oxymask

Primary outcome measures

  • 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 outcome measures (9)
  • Lowest SpO2 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 [Time frame: First 24 hours after randomisation]
  • Lowest PaO2/FiO2 ratio during the intervention period [Time frame: Maximum 4 hours after start of intervention postoperatively]
  • Subjective patient comfort (visual scale 0-10) [Time frame: Maximum 4 hours after start of intervention]
  • Length of stay (LOS) in the postoperative unit [Time frame: Up to 7 days after surgery]
  • Length of stay in hospital [Time frame: From surgery up until 30 days after surgery]
  • Mortality in hospital [Time frame: Up until 30 days after surgery]
  • 30-days mortality [Time frame: 30 days after surgery]
  • Healthy days at home 30 days after surgery [Time frame: 30 days postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Stockholm

Identifiers

NCT: NCT07464730 · 2026-00273-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗