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NCT Number: NCT07464730

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

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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Key information

Conditions

Postoperative Pulmonary Complications (PPCs)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

Location status: Recruiting

Location contact

Ida-Maria Forsberg, Consultant, PhD

CONTACT

[email protected]

+ 46 8 5177 0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Oxygen

Combination Product

High flow nasal oxygen will be administered in the intervention group

Oxygen

Combination Product

Oxygen delivered by nasal cannula or oxymask

Primary outcomes

  1. 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

  1. Lowest SpO2 the first 2 and 24 h after randomisation

    Time frame: 24 hours after randomisation

    Lowest oxygen saturation registered in the chart during the first 2 and 24 h after randomisation

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

    Time frame: First 24 hours after randomisation

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

  3. Lowest PaO2/FiO2 ratio during the intervention period

    Time frame: 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)

  4. Subjective patient comfort (visual scale 0-10)

    Time frame: Maximum 4 hours after start of intervention

    Patients will report their comfort with each method, HFNO or COT after the intervention

  5. Length of stay (LOS) in the postoperative unit

    Time frame: Up to 7 days after surgery

    The duration of stay in the postoperative unit will be registered and compared between the groups

  6. Length of stay in hospital

    Time frame: From surgery up until 30 days after surgery

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

  7. Mortality in hospital

    Time frame: Up until 30 days after surgery

    Mortality during hospital admission after surgery

  8. 30-days mortality

    Time frame: 30 days after surgery

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

  9. Healthy days at home 30 days after surgery

    Time frame: 30 days postoperatively

    Number of healthy days at home 30 days after surgery compared between the groups

Study contacts

Contact information is provided by the study sponsor or research team.

Ida-Maria Forsberg, PhD

CONTACT

[email protected]

+46704381445

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Acronym: Hi-POP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 11, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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