A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

Официальное название

A Randomized Controlled Trial on the Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

Обзор

Patients at high risk of post-operative pulmonary complications (PPC) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the HFNC group and control group, which uses conventional nasal cannula oxygen therapy. The primary outcome is the incidence of PPC, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

Подробное описание

This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

Вмешательства

• Устройство heated humidified high flow nasal cannula oxygen therapy, HFNC
  HFNC can accurately provide 21% \~ 100% oxygen concentration through air oxygen mixer. And through the heating and humidification device to provide 37℃, relative humidity of 100% gas, the maximum flow of 70L/min.
• Устройство Nasal cannula oxygen
  Nasal cannula oxygen has become a routine part of postoperative treatment

Первичные конечные точки

• Postoperative pulmonary complication [Срок оценки: 7 days after the surgery]

Вторичные конечные точки (5)

• Total Hospitalization days [Срок оценки: 7 days after the surgery]
• Oxygen therapy [Срок оценки: 2 days after the surgery]
• Antibiotics [Срок оценки: 7 days after the surgery]
• Postoperative oxygenation [Срок оценки: 2 days after the surgery]
• Adverse events [Срок оценки: 2 days after the surgery]

Критерии участия

Критерии включения

• Patients with gynecologic Neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest CT scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met:

• Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points;
• BMI≥30;
• Moderate to severe asthma;
• Moderate to severe chronic obstructive pulmonary disease (COPD);
• Smoking history ≥20 packs/year

Критерии исключения

• Patients with lung metastasis of malignant tumor or primary lung malignant tumor;
• previous lung surgery or radiotherapy;
• the surgery involved segmental bowel resection.

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

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sichuan Cancer Hospital and Research Institute — Чэнду

Публикации

• Chaudhuri D, Granton D, Wang DX, Burns KEA, Helviz Y, Einav S, Trivedi V, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Mbuagbaw L, Hodgson CL, Jaber S, Goligher EC, Brochard L, Rochwerg B. High-Flow Nasal Cannula in the Immediate Postoperative Period: A Systematic Review and Meta-analysis. Chest. 2020 Nov;158(5):1934-1946. doi: 10.1016/j.chest.2020.06.038. Epub 2020 Jun PMID 32615190
• Leone M, Einav S, Chiumello D, Constantin JM, De Robertis E, De Abreu MG, Gregoretti C, Jaber S, Maggiore SM, Pelosi P, Sorbello M, Afshari A; Guideline contributors. Noninvasive respiratory support in the hypoxaemic peri-operative/periprocedural patient: a joint ESA/ESICM guideline. Intensive Care Med. 2020 Apr;46(4):697-713. doi: 10.1007/s00134-020-05948-0. Epub 2020 Mar 10. PMID 32157356
• Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 20 PMID 27771739

Идентификаторы

NCT: NCT05526534 · HFNC202205.V1.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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