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

This study is not yet open for participant recruitment.
Verified January 2013 by Prince of Songkla University
Sponsor:
Information provided by (Responsible Party):
Panthila Rujirojindakul, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01763177
First received: January 4, 2013
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Post-operative Sore Throat at Post-anesthetic Care Unit and 24-h Post-operative
 Other: Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • The effect of oxygen nebulizer therapy on post-operative sore throat [ Time Frame: at post-anesthetic care unit and 24-h post-operative ] [ Designated as safety issue: Yes ]

    Assess POST using scoring system and discomfort by interview. Sore throat scoring system is divided into 4 scores 0 means no sore throat

    1. means minimal sore throat (less severe than cold)
    2. means moderate sore throat (similar to cold)
    3. 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 [ Time Frame: 24-h post-op and 30-d mortality ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1036
Study Start Date: January 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No oxygen
No given oxygen at post-anesthetic care unit
Active Comparator: Oxygen
Oxygen nebulizer via face mask, FiO2 0.4, flow 8 LPM for 30 minutes
 Other: Oxygen

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • Pre-operative Hb >10 g% or Hct > 30%
  • ASA I-III
  • Elective surgery
  • General anesthesia with oroendotracheal tube using Macintosch 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763177

Locations
Thailand
Department of anesthesiology, Faculty of Medicine, Prince of Songkla University Recruiting
Hat Yai, Songkhla, Thailand, 90110
Contact: Panthila Rujirojindakul, M.D.     +66815434872     rpanthi@medicine.psu.ac.th    
Principal Investigator: Panthila Rujirojindakul, M.D.            
Sponsors and Collaborators
Prince of Songkla University
  More Information

Additional Information:
oxygen nebulizer AND sore throat  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Panthila Rujirojindakul, Assistant Professor Dr.Panthila Rujirojindakul, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01763177     History of Changes
Other Study ID Numbers: EC56-008-08-1-1
Study First Received: January 4, 2013
Last Updated: January 8, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
nebulizer
oxygen
post-operative sore throat

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013