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

ConditionPostoperative Pulmonary Complications (PPCs)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 65 years

BMI >30

Preoperative SpO2 <95 %

Scheduled for lobectomy or pulmonary segment resection

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: HFNOExperimental treatment 1 intervention
Group B: Conventional oxygen therapy (COT)Active comparator 1 intervention

Trial outcomes

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

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

Time frame
24 hours after randomisation
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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