Effect of Suctioning by Bronchoscope on Postoperative Pulmonary Complications Among Patients With SCI in the PACU

NCT04879602 | Unknown DMC

• 1 other identifier: 2021-0162
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory failure and dyspnea are common in spinal cord injury (SCI), and in acute situations, any spinal cord lesion above T11 can cause abnormal respiratory function and impair the airway clearance. Although surgical decompression is one of the key early neuroprotective therapies, surgery and general anesthesia disrupt many aspects of respiratory function and may cause a series of postoperative pulmonary complications. Endotracheal suction is important to reduce the risk of lung consolidation and atelectasis. But for patients with respiratory insufficiency such as SCI, ordinary suction is not enough to clear secretions in the deeper airways. And repeated intratracheal suction may even cause some serious complications. Bronchoscopy can generally penetrate into the bronchus of grade 3-4, and fully attract the secretions in it under visual conditions. Its curative effect on pneumonia and atelectasis in the ICU has been affirmed, but no one has yet explored the application in the postoperative care unit .

Conditions

Spinal Cord Injuries

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 postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis including respiratory infection, respiratory failure,pleural effusion, atelectasis, pneumothorax , broncospasm and aspiration pneumonitis

  within 7 days after operation or before discharge, whichever came first

Study Arms (2)

Bronchoscopy group

EXPERIMENTAL

patients receive suction before extubation by bronchoscopy in PACU

Behavioral: suction with bronchoscopy

Control group

NO INTERVENTION

patients receive routine ordinary suction in PACU

Interventions

suction with bronchoscopy BEHAVIORAL

suction with bronchoscopy

Bronchoscopy 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 Spinal injury level :above T11 Stable preoperative spontaneous respiration Elective cervical/thoracic spine fixation American Spinal Injury Association (ASIA) class: A-D

You may not qualify if:

• \- Unconscious before surgery Pregnant With mental disorders Directly transfered to ICU

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Suction; Bronchoscopy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 10, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)