Inhaled NO in Surgical Patients With Recent COVID-19 Infection

NCT05721144 | Completed Phase 2 DMC

• 1 other identifier: KY-20230079
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nitric Oxide Inhalation; Postoperative Pulmonary Complications; Surgery; COVID-19

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complications

  It is composite outcome including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis

  within 7 days after operation

Secondary Outcomes (7)

• mortality within 30 days postoperatively

  within 30 days after operation

• Classification of pulmonary complications (Clavien-Dindo)

  within 7 days after operation

• the rate of unplanned ICU admission

  within 7 days after operation

• postoperative length of hospital stay

  From the date of surgery until the date patient discharge from hospital, assessed up to 30 days

• Incidence of thrombotic events

  From the date of surgery until the date patient discharge from hospital, assessed up to 30 days

Other Outcomes (6)

• Incidence of hypotension

  From anesthesia induction until leave operation room, assessed up to 12 hrs

• Incidence of hypertension

  During surgery, from anesthesia induction to end of anesthesia

• Occurrence of arrhythmia

  From anesthesia induction until leave operation room, assessed up to 12 hrs

Study Arms (2)

Experimental: Treatment Group

EXPERIMENTAL

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. The physician will follow their own institutional weaning protocols.

Drug: Nitric Oxide Gas

Sham Comparator: Control Group

NO INTERVENTION

The delivery system will be set up anyway without studying gas administration

Interventions

Nitric Oxide Gas DRUG

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.

Also known as: Nitric Oxide inhalation

Experimental: Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Planned for surgery under general anesthesia
• With a history of COVID-19 infection within 7 weeks prior to surgery.

You may not qualify if:

• Physician makes a decision that trial involvement is not in the patient's best interest or any condition that does not allow the protocol to be followed safely
• ASA ≥ IV, life expectancy\< 24 h.
• Pregnant or lactating women.
• Severe liver disease (Child-Pugh score ≥ 12).
• Patients with severe respiratory failure need mechanical ventilation support or ECMO life support before the operation.
• Severe renal dysfunction (eGFRC≤30 ml/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, and peritoneal dialysis.
• Having received or participated in other clinical trials within the previous month.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (21)

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  PMID: 38485487 DERIVED

MeSH Terms

Conditions

COVID-19; Postoperative Complications

Interventions

Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Chong Lei, MD&phD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 9, 2023
• Study Start: February 17, 2023
• Primary Completion: April 14, 2024
• Study Completion: May 7, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 12 months
• Access Criteria: Investigators who provide a methodologically sound proposal and whose proposed use of data has been approved by the steering of INORDINATE identified for individual participant data meta-analysis. Proposals should be directed to corresponding author of the publication. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)