NCT07464730

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Mar 2029

First Submitted

Initial submission to the registry

February 19, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2029

Last Updated

May 14, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 19, 2026

Last Update Submit

May 11, 2026

Conditions

Postoperative Pulmonary Complications (PPCs)

Keywords

HFNOHigh flow nasal oxygenPostoperative pulmonary complication

Outcome Measures

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

    Up to 7 days after surgery

Secondary Outcomes (9)

  • Lowest SpO2 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

    First 24 hours after randomisation

  • Lowest PaO2/FiO2 ratio during the intervention period

    Maximum 4 hours after start of intervention postoperatively

  • Subjective patient comfort (visual scale 0-10)

    Maximum 4 hours after start of intervention

  • Length of stay (LOS) in the postoperative unit

    Up to 7 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

HFNO

EXPERIMENTAL

Group of patients receiving HFNO postoperatively

Combination Product: High Flow Oxygen

Conventional oxygen therapy (COT)

ACTIVE COMPARATOR

Group of patients receiving conventional oxygen therapy postoperatively

Combination Product: Oxygen

Interventions

High Flow OxygenCOMBINATION_PRODUCT

High flow nasal oxygen will be administered in the intervention group

HFNO
OxygenCOMBINATION_PRODUCT

Oxygen delivered by nasal cannula or oxymask

Conventional oxygen therapy (COT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Central Study Contacts

Ida-Maria Forsberg, PhD

CONTACT

+46704381445ida-maria.forsberg@regionstockholm.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 11, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

March 9, 2028

Study Completion (Estimated)

March 9, 2029

Last Updated

May 14, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)