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

NCT ID: NCT04860648

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 592 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2022-03-31

Brief Summary

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.

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.

Conditions

Postoperative Respiratory Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

LUS group

patients receive lung ultrasound examination, and doctors give the treatment according to the LUS results

Group Type: EXPERIMENTAL

lung ultrasound

Intervention Type: OTHER

doctors treat the patients combining the Lus results and clinical practice

Control group

patients receive no lung ultrasound examination and other intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

lung ultrasound

doctors treat the patients combining the Lus results and clinical practice

Intervention Type: OTHER

Other Intervention Names

doctors' clinical decision

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan, MD

Role: STUDY_CHAIR

Zhejiang University

Locations

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Min Yan, MD

Role: CONTACT

zryanmin@zju.edu.cn

13757118632

Facility Contacts

Min Yan, Doctor

Role: primary

zryanmin@zju.edu.cn

13757118632 ext. 13252017900

Other Identifiers

2021-0127

Identifier Type: -

Identifier Source: org_study_id