- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961075
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
January 23, 2017 updated by: The Second Affiliated Hospital of Dalian Medical University
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fiberoptic bronchoscopy (FOB) is the essential procedures for diagnosis and treatment of respiratory diseases。 Fever following FOB has been frequently reported.
Fever is usually caused by patient discomfort and delay recovery from illness, or even worse.
The reported frequency of this complication ranges from 1 to 20%.
According to previous reports, postbronchoscopy fever is associated with advanced age, the presence of abnormal bronchoscopic findings,documented endobronchial obstruction, bronchoscopic intervention for malignancy, BAL, bronchial brushing, endotoxin contamination during bronchoscopy, instillation of topical anesthetic through the bronchoscope, abnormal differential cell counts in the BAL fluid (BALF), bacterial growth in the BALF culture,and the severity of bleeding.
At present, guidelines recommend sedation and analgesia combined with airway surface anesthesia for Fiberoptic bronchoscopy.
laryngeal spray and cricothyroid anesthesia often used in clinical.Cricothyroid local anesthesia has a good effect, but it is an invasive operation, this is risk factors for fever after bronchoscopy.Therefore, to compare fever in the two kinds of airway anesthesia on Bronchoscopy .
So as to provide the local anesthesia method with little influence on the patient.
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Dalian, Liaoning, China, 116000
- The Second Hospital of Dalian Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-III
Exclusion Criteria:
- use of immunosuppressive agents or corticosteroids
- body temperature 37.3°C during the 24 h prior to FOB,intubation or mechanical ventilation
- therapeutic bronchoscopy (foreign body removal, bronchial toilet, or stenting), discharge within 24 h of FOB
- surgical or diagnostic procedures within 24 h of FOB.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cricothyroid
local surface anesthesia by Cricothyroid
|
Airway anesthesia for Bronchoscopy
|
Experimental: Laryngeal tube
local surface anesthesia by Laryngeal tube
|
Airway anesthesia for Bronchoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fever
Time Frame: 48 hour
|
Fever was defined as an axillary body temperature 37.3°C
|
48 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Xiao z yang, MD,PhD, 0866-17709873399
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
November 9, 2016
First Submitted That Met QC Criteria
November 9, 2016
First Posted (Estimate)
November 10, 2016
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- post2016taper
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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