NCT01763177

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,036

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration 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

January 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2.4 years

First QC Date

January 4, 2013

Last Update Submit

November 15, 2015

Conditions

Pain, Postoperative

Keywords

nebulizeroxygenpost-operative sore throat

Outcome Measures

Primary Outcomes (1)

  • 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 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)

    at post-anesthetic care unit and 24-h post-operative

Secondary Outcomes (1)

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

    24-h post-op and 30-d mortality

Study Arms (2)

No oxygen

NO INTERVENTION

No given oxygen at post-anesthetic care unit

Oxygen

ACTIVE COMPARATOR

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

Other: Oxygen

Interventions

OxygenOTHER

Oxygen mask 40% 8 LPM for 30 minutes

Oxygen

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

  • oxygen nebulizer AND sore throat

    BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Panthila Rujirojindakul, MD

    Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.Panthila Rujirojindakul

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

TH(1)