Inhaled NO in Surgical Patients With Recent COVID-19 Infection
NCT05721144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 660
Last updated 2024-05-10
Summary
The aim of this study is to evaluate the effect of perioperative inhalation of NO on reducing the incidence of postoperative pulmonary complications in patients with recent COVID-19 infection, and to evaluate whether inhaled NO can improve the prognosis of patients.
The investigators will enroll 660 surgical patients who was infected with SARS-CoV-2 within 42days (7 weeks ) prior to planed surgery under general anesthesia. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or a placebo. Perioperative standards of care will be the institution's own protocols (such as ventilation strategies and use and dose of anesthetics, analgesia and fluid management, etc).
Conditions
- Nitric Oxide
- COVID-19
- Surgery
- Postoperative Complications
Interventions
- DRUG
-
Nitric Oxide Gas
Inspired NO/N2 will be delivered at 80 parts per million (ppm) after anesthesia induction and intubation and lasted until the end of surgery and leave the operating room.
Sponsors & Collaborators
-
Xijing Hospital
lead OTHER
Principal Investigators
-
Chong Lei, MD&phD · Xijing Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-17
- Primary Completion
- 2024-04-14
- Completion
- 2024-05-07
Countries
- China
Study Locations
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