Pain, PostoperativePOSTNCT01763177
Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
A study testing Oxygen in people with Pain, Postoperative, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
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.
- Conditions
- Pain, Postoperative
- Being tested
- Oxygen
- Keywords
- nebulizer, oxygen, post-operative sore throat
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
Oxygen mask 40% 8 LPM for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 24-h post-op and 30-d mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panthila Rujirojindakul, Prince of Songkla University
- Investigators
- Panthila Rujirojindakul, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763177
- Sponsor's protocol ID
- EC56-008-08-1-1
- Acronym
- POST
- Status last verified
- Nov 2015
- First submitted
- 4 Jan 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
oxygen nebulizer AND sore throat
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
- ClinicalTrials.gov ID
- NCT01763177
- Acronym / sponsor ID
- POST / EC56-008-08-1-1
- Conditions
- Pain, Postoperative
- Keywords
- nebulizer, oxygen, post-operative sore throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,036 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No oxygen | No intervention | –No given oxygen at post-anesthetic care unit |
| Oxygen | Active comparator | Other: OxygenOxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenOxygen mask 40% 8 LPM for 30 minutes | Other | Oxygen |
Primary outcome
The effect of oxygen nebulizer therapy on post-operative sore throat
Time frame: at post-anesthetic care unit and 24-h post-operative
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Backgroundoxygen nebulizer AND sore throat
- oxygen nebulizer AND sore throatLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panthila Rujirojindakul, MD principal investigator
Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Pain, Postoperative, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of oxygen nebulizer therapy on post-operative sore throat (time frame: at post-anesthetic care unit and 24-h post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.