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

NCT ID: NCT04879602

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-12-31

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 .

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.

Conditions

Spinal Cord Injuries

Study Design

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

Study Groups

Bronchoscopy group

patients receive suction before extubation by bronchoscopy in PACU

Group Type: EXPERIMENTAL

suction with bronchoscopy

Intervention Type: BEHAVIORAL

suction with bronchoscopy

Control group

patients receive routine ordinary suction in PACU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

suction with bronchoscopy

suction with bronchoscopy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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 Medical College

Hangzhou, Zhejiang, China

Site Status: RECRUITING

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

15888210247

Other Identifiers

2021-0162

Identifier Type: -

Identifier Source: org_study_id