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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 20, 2014
Last verified: February 2014
  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
Pain, Postoperative
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:


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, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes
Other: Oxygen
Oxygen mask 40% 8 LPM for 30 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: February 20, 2014
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Pharyngitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014