Postoperative Pulmonary Complications (PPCs)Hi-POPNCT07464730
Postoperative High-flow Nasal Oxygenation After High-risk Surgery in the Frail Adult
A study testing High Flow Oxygen and Oxygen in people with Postoperative Pulmonary Complications (PPCs), run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- High Flow Oxygen and Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 20 Apr 2026to 9 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 %
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Ida-Maria Forsberg, Consultant, PhD, + 46 8 5177 0000, ida-maria.forsberg@regionstockholm.se
About this study
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.
- Being tested
- High Flow Oxygen, Oxygen
- Keywords
- HFNO, High flow nasal oxygen, Postoperative pulmonary complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow OxygenCombination product
High flow nasal oxygen will be administered in the intervention group
OxygenCombination product
Oxygen delivered by nasal cannula or oxymask
| Study group | Role | What they receive |
|---|---|---|
| HFNO | Experimental | Group of patients receiving HFNO postoperatively Receives: Combination Product: High Flow Oxygen |
| Conventional oxygen therapy (COT) | Active comparator | Group of patients receiving conventional oxygen therapy postoperatively Receives: Combination Product: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 days after surgery
Secondary outcomes (9)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to 7 days after surgery
Length of stay in hospital
The length of stay in hospital after surgery will be recorded and compared
Measured: From surgery up until 30 days after surgery
Mortality in hospital
Mortality during hospital admission after surgery
Measured: Up until 30 days after surgery
30-days mortality
30-days mortality, number and proportion of patients between the groups
Measured: 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
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 Apr 2026
- Primary completion9 Mar 2028 (estimated)
- Study completion9 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464730
- Sponsor's protocol ID
- 2026-00273-01
- Acronym
- Hi-POP
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative High-flow Nasal Oxygenation After High-risk Surgery in the Frail Adult
- ClinicalTrials.gov ID
- NCT07464730
- Acronym / sponsor ID
- Hi-POP / 2026-00273-01
- Keywords
- HFNO, High flow nasal oxygen, Postoperative pulmonary complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 9 Mar 2028 (estimated)
- Study completion
- 9 Mar 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNO | Experimental | Combination Product: High Flow OxygenGroup of patients receiving HFNO postoperatively |
| Conventional oxygen therapy (COT) | Active comparator | Combination Product: OxygenGroup of patients receiving conventional oxygen therapy postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Age > 65 years
- BMI >30
- Preoperative SpO2 <95 %
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow OxygenHigh flow nasal oxygen will be administered in the intervention group | Combination product | HFNO |
| OxygenOxygen delivered by nasal cannula or oxymask | Combination product | Conventional oxygen therapy (COT) |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Oxygen and Oxygen in people with Postoperative Pulmonary Complications (PPCs), run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida-Maria Forsberg, PhD (+46704381445, ida-maria.forsberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.