Lung Ultrasound Guided Prevention of Postoperative Pulmonary Complications in Moderate to High Risk Patients

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. According to European Perioperative Clinical Outcome definitions, major pulmonary complications include atelectasis, respiratory infection, pleural effusion, and pneumothorax. Because identifying patients at high risk for PPCs may allow earlier treatment, predictive scores ( the Assess Respiratory Risk in Surgical Patients in Catalonia score [ARISCAT]) have been developed.Lung ultrasound (LUS) is more accurate than chest X-ray in diagnosing pulmonary complications, and lung ultrasound performed in the postanesthesia care unit may identify patients at higher risk for pulmonary complications. So we aimed to study if lung ultrasound can guide the prevention of PPCs in moderate to high risk patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Respiratory Complication
• Intervention / Treatment: Other: lung ultrasound

Detailed Description

patients recruited are randomized into the two groups: LUS group and Control group. Patients in LUS group received ultrasound examination and guided the treatment according to the ultrasound results, while the control group did not receive ultrasound examination, just the same as the routine clinical practice. This study aims to explore whether ultrasound-guided clinical treatment can reduce the incidence of postoperative pulmonary complications in moderate to highrisk patients. Before operation, informed consent was signed according to the inclusion criteria, and the incidence of pulmonary complications within 5 days after operation (or before discharge) was recorded after operation.

• Study Type: Interventional
• Enrollment (Anticipated): 592
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age≥18 Estimated ARISCAT score ≥26分

Exclusion Criteria:

• transferred to ward or ICU directly day surgery (patients won't stay in hospital longer than 24 hours after surgery actual ARISCAT score < 26分 the technical incompatibility of the acoustic window patients refused pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LUS group; patients receive lung ultrasound examination, and doctors give the treatment according to the LUS results	Other: lung ultrasound; doctors treat the patients combining the Lus results and clinical practice; Other Names: doctors' clinical decision
NO_INTERVENTION: Control group; patients receive no lung ultrasound examination and other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of postoperative pulmonary complications	postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis	within 5 days after operation or before discharge, whichever came first

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (ACTUAL): April 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: lung ultrasound, postoperative pulmonary complications
• Other Study ID Numbers: 2021-0127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No