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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: Up to 7 days after surgery]

Вторичные конечные точки (9)

• Lowest SpO2 the first 2 and 24 h after randomisation [Срок оценки: 24 hours after randomisation]
• Desaturation (SpO2 <90%) the first 2 or 4 and under 24 hours after randomisation [Срок оценки: First 24 hours after randomisation]
• Lowest PaO2/FiO2 ratio during the intervention period [Срок оценки: Maximum 4 hours after start of intervention postoperatively]
• Subjective patient comfort (visual scale 0-10) [Срок оценки: Maximum 4 hours after start of intervention]
• Length of stay (LOS) in the postoperative unit [Срок оценки: Up to 7 days after surgery]
• Length of stay in hospital [Срок оценки: From surgery up until 30 days after surgery]
• Mortality in hospital [Срок оценки: Up until 30 days after surgery]
• 30-days mortality [Срок оценки: 30 days after surgery]
• Healthy days at home 30 days after surgery [Срок оценки: 30 days postoperatively]

Критерии участия

Критерии включения

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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Швеция · 1 центр

• Karolinska University Hospital — Stockholm

Идентификаторы

NCT: NCT07464730 · 2026-00273-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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