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

NCT04860648 | Unknown DMC

• 1 other identifier: 2021-0127
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Respiratory Complication

Keywords

lung ultrasound, postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

LUS group

EXPERIMENTAL

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

Other: lung ultrasound

Control group

NO INTERVENTION

patients receive no lung ultrasound examination and other intervention

Interventions

lung ultrasound OTHER

doctors treat the patients combining the Lus results and clinical practice

Also known as: doctors' clinical decision

LUS group

Eligibility Criteria

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

You may qualify if:

• Age≥18 Estimated ARISCAT score ≥26分

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Min Yan, MD

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Min Yan, MD

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-03

Locations

CN (1)