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

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
suction with bronchoscopy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bronchoscopy group

Control group

Arm Description

patients receive suction before extubation by bronchoscopy in PACU

patients receive routine ordinary suction in PACU

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 6, 2021
Last Updated
February 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04879602
Brief Title
Effect of Suctioning by Bronchoscope on Postoperative Pulmonary Complications Among Patients With SCI in the PACU
Official Title
Second Affiliated Hospital of Zhejiang University,School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: one group receives routine ordinary sputum suction ; the other group receives routine ordinary sputum suction with bronchoscopy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscopy group
Arm Type
Experimental
Arm Description
patients receive suction before extubation by bronchoscopy in PACU
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients receive routine ordinary suction in PACU
Intervention Type
Behavioral
Intervention Name(s)
suction with bronchoscopy
Intervention Description
suction with bronchoscopy
Primary Outcome Measure Information:
Title
the incidence of postoperative pulmonary complications
Description
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
Time Frame
within 7 days after operation or before discharge, whichever came first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Yan, MD
Phone
13757118632
Email
zryanmin@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Yan, MD
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Phone
15888210247
Email
zryanmin@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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