NCT02961075

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
Last Updated

January 25, 2017

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 9, 2016

Last Update Submit

January 23, 2017

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Fever

    Fever was defined as an axillary body temperature 37.3°C

    48 hour

Study Arms (2)

Cricothyroid

EXPERIMENTAL

local surface anesthesia by Cricothyroid

Other: local surface anesthesia

Laryngeal tube

EXPERIMENTAL

local surface anesthesia by Laryngeal tube

Other: local surface anesthesiaDevice: Laryngeal tube

Interventions

local surface anesthesiaOTHER

Airway anesthesia for Bronchoscopy

CricothyroidLaryngeal tube
Laryngeal tubeDEVICE
Laryngeal tube

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiao z yang, MD,PhD

    0866-17709873399

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 10, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 25, 2017

Record last verified: 2016-11

Locations

CN(1)