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

Second Affiliated Hospital of Zhejiang University,School of Medicine

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 .

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: suction with bronchoscopy

Detailed Description

All patients admitted to PACU with tracheal tube after operation will be recruited, and than be randomly divided into two groups during resuscitation:

1. one group receives routine ordinary sputum suction ; the other group receives routine ordinary sputum suction with bronchoscopy
2. After entering the PACU, both groups will receive two lung ultrasound examinations and record the lung ultrasound scores: when entering PACU and when leaving PACU.

After returning to the ward, the doctor in charge will make medical decisions and treatments based on the condition.

Follow up for pulmonary complications (respiratory tract infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, pulmonary edema, pulmonary embolism, aspiration pneumonia) within 7 days after surgery.

Follow-up 30 days and 90 days after operation.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronchoscopy group; patients receive suction before extubation by bronchoscopy in PACU	Behavioral: suction with bronchoscopy; suction with bronchoscopy
No Intervention: Control group; patients receive routine ordinary suction in PACU

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 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2021-0162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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