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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorSichuan Cancer Hospital and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Patients with lung metastasis of malignant tumor or primary lung malignant tumor;

previous lung surgery or radiotherapy;

the surgery involved segmental bowel resection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • heated humidified high flow nasal cannula oxygen therapy, HFNC

    Device

    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.

  • Nasal cannula oxygen

    Device

    Nasal cannula oxygen has become a routine part of postoperative treatment

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: HFNC groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pulmonary complication

The primary outcome measures were the incidence of PPC in the treatment group and the control group, including the incidence of postoperative hypoxemia, atelectasis, pneumonia, etc.

Time frame
7 days after the surgery

Secondary outcomes

1

Total Hospitalization days

Postoperative Hospitalization Days and ICU Stay Days

Time frame
7 days after the surgery
2

Oxygen therapy

The Need for Oxygen Therapy

Time frame
2 days after the surgery
3

Antibiotics

The use of antibiotics, including the type, usage, use time, etc.

Time frame
7 days after the surgery
4

Postoperative oxygenation

Improvement of Postoperative Oxygenation

Time frame
2 days after the surgery

Other outcomes

Sponsors and contacts

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