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Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat (POST)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Oxygen
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring nebulizer, oxygen, post-operative sore throat

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75 years
  • Pre-operative Hb >10 g% or Hct > 30%
  • American Society of Anesthesiologist (ASA) class I-III
  • Elective surgery
  • General anesthesia with oroendotracheal tube using Macintosh laryngoscope
  • Not exposed to intraoperative nitrous oxide
  • Oxygen saturation at room air > 95% before induction and at arrival the PACU

Exclusion Criteria:

  • Cases needing ICU admission immediately post-operative
  • Conditioning requiring post-operative oxygen therapy e.g. heart disease, pregnancy, morbid obesity, cardiac and thoracic surgery
  • Patients' conditioning affecting to complication of nebulizer oxygen therapy e.g. pulmonary disease, bleomycin treatment
  • Patient's conditioning affecting POST assessment e.g. pre-operative using ventilator, recent upper respiratory tract infection (URI), recent lower respiratory tract infection and history of difficult airway
  • Surgical conditioning affecting POST e.g. airway surgery, oral surgery, esophageal and neck surgery

Sites / Locations

  • Department of anesthesiology, Faculty of Medicine, Prince of Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No oxygen

Oxygen

Arm Description

No given oxygen at post-anesthetic care unit

Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes

Outcomes

Primary Outcome Measures

The effect of oxygen nebulizer therapy on post-operative sore throat
Assess POST using scoring system and discomfort by interview. Sore throat scoring system is divided into 4 scores 0 means no sore throat means minimal sore throat (less severe than cold) means moderate sore throat (similar to cold) means severe sore throat (more severe than cold)

Secondary Outcome Measures

To evaluate the adverse events (pulmonary complications, wound infection, and mortality) of post-operative complications related to oxygen therapy

Full Information

First Posted
January 4, 2013
Last Updated
November 15, 2015
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT01763177
Brief Title
Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Acronym
POST
Official Title
Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat (POST). Oxygen nebulizer therapy increases humidity to the airway, especially post-extubation. Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
nebulizer, oxygen, post-operative sore throat

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1036 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No oxygen
Arm Type
No Intervention
Arm Description
No given oxygen at post-anesthetic care unit
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
Oxygen mask 40% 8 LPM for 30 minutes
Primary Outcome Measure Information:
Title
The effect of oxygen nebulizer therapy on post-operative sore throat
Description
Assess POST using scoring system and discomfort by interview. Sore throat scoring system is divided into 4 scores 0 means no sore throat means minimal sore throat (less severe than cold) means moderate sore throat (similar to cold) means severe sore throat (more severe than cold)
Time Frame
at post-anesthetic care unit and 24-h post-operative
Secondary Outcome Measure Information:
Title
To evaluate the adverse events (pulmonary complications, wound infection, and mortality) of post-operative complications related to oxygen therapy
Time Frame
24-h post-op and 30-d mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years Pre-operative Hb >10 g% or Hct > 30% American Society of Anesthesiologist (ASA) class I-III Elective surgery General anesthesia with oroendotracheal tube using Macintosh laryngoscope Not exposed to intraoperative nitrous oxide Oxygen saturation at room air > 95% before induction and at arrival the PACU Exclusion Criteria: Cases needing ICU admission immediately post-operative Conditioning requiring post-operative oxygen therapy e.g. heart disease, pregnancy, morbid obesity, cardiac and thoracic surgery Patients' conditioning affecting to complication of nebulizer oxygen therapy e.g. pulmonary disease, bleomycin treatment Patient's conditioning affecting POST assessment e.g. pre-operative using ventilator, recent upper respiratory tract infection (URI), recent lower respiratory tract infection and history of difficult airway Surgical conditioning affecting POST e.g. airway surgery, oral surgery, esophageal and neck surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panthila Rujirojindakul, MD
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Citations:
Citation
oxygen nebulizer AND sore throat
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/
Description
oxygen nebulizer AND sore throat

Learn more about this trial

Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

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