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

Postoperative Respiratory Complication Clinical Trial

Official title:

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04860648
• Other study ID #: 2021-0127
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Yan, MD
• Phone: 13757118632
• Email: zryanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 592
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age=18 Estimated ARISCAT score =26?

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? the technical incompatibility of the acoustic window patients refused pregnant

Related Conditions & MeSH terms

• Postoperative Respiratory Complication

Intervention

Other:
• lung ultrasound
doctors treat the patients combining the Lus results and clinical practice

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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