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Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
local surface anesthesia
Laryngeal tube
Sponsored by
The Second Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Second Hospital of Dalian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cricothyroid

Laryngeal tube

Arm Description

local surface anesthesia by Cricothyroid

local surface anesthesia by Laryngeal tube

Outcomes

Primary Outcome Measures

Fever
Fever was defined as an axillary body temperature 37.3°C

Secondary Outcome Measures

Full Information

First Posted
November 9, 2016
Last Updated
January 23, 2017
Sponsor
The Second Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02961075
Brief Title
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
Official Title
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Dalian Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cricothyroid
Arm Type
Experimental
Arm Description
local surface anesthesia by Cricothyroid
Arm Title
Laryngeal tube
Arm Type
Experimental
Arm Description
local surface anesthesia by Laryngeal tube
Intervention Type
Other
Intervention Name(s)
local surface anesthesia
Intervention Description
Airway anesthesia for Bronchoscopy
Intervention Type
Device
Intervention Name(s)
Laryngeal tube
Primary Outcome Measure Information:
Title
Fever
Description
Fever was defined as an axillary body temperature 37.3°C
Time Frame
48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao z yang, MD,PhD
Organizational Affiliation
0866-17709873399
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China

12. IPD Sharing Statement

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Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study

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