Postoperative Respiratory ComplicationsPhase 4NCT01562691
Effect of Airway Integrated Nasal Packing With Different Material
A Phase 4 study testing Nasopore, airway integrated Nasopore and airway-integrated Vaseline gauze in people with Postoperative Respiratory Complications and Pain, Postoperative., run by Chi Mei Medical Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Postoperative Respiratory Complications, Pain, Postoperative.
- What is being tested?
- Nasopore, airway integrated Nasopore and airway-integrated Vaseline gauze
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 4
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis
Who cannot join
- patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze
The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery.
Read the detailed description
Nasal packing with integrated airway had been claimed to improve body oxygenation following septal surgery. This randomized control study examined the effect of airway integrated with nasal packing, in terms of its improvement on oxygen saturation. Sixty patients with septal deviation and hypertrophic turbinate were randomized into three groups. Group 1 patients were packed with only nasopore@ after surgery. Nasopore@ with integrated airway was used for group 2 patients; and Vaseline gauze integrated with airway for group 3 patients. Hemodynamic parameters were sequentially checked. Nasal pain sensation was recorded using visual analog scale.
- Being tested
- Nasopore, airway integrated Nasopore, airway-integrated Vaseline gauze
- Keywords
- nasal packing, nasal airway, septoplasty, oxygen saturation, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NasoporeProcedure or surgery
Bilateral nasal packing using Nasopore without airway integrated
airway integrated NasoporeProcedure or surgery
post nasoseptoplasty with nasal packing using airway integrated Nasopore
airway-integrated Vaseline gauzeProcedure or surgery
post nasal septoplasty with packing using airway-integrated Vaseline gauze
| Study group | Role | What they receive |
|---|---|---|
| Nasopore only | Experimental | Packing using nasopore without airway integrated Receives: Procedure: Nasopore |
| nasopore with airway integrated | Active comparator | packing using airway integrated nasopore Receives: Procedure: airway integrated Nasopore |
| airway-integrated Vaseline gauze | Active comparator | Nasal packing using airway-integrated Vaseline gauze Receives: Procedure: airway-integrated Vaseline gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxyhemoglobin saturation by pulse oximetry, SpO2
SpO2 was measured 30 minutes before operation using O2 saturation monitor.
Measured: SpO2 was measured 30 minutes before operation,
change of SpO2 from baseline to 4 hours post-operation
records of the SpO2 at 4 hours post-operation
Measured: records of the SpO2 at 4 hours post-operation
change of the SpO2 from baseline to 6 hours post-operation
records of the SpO2 at 6 hours post-operation
Measured: records of the SpO2 at 6 hours post-operation
change of the SpO2 from baseline to 12 hours post-operation
records of the SpO2 at 12 hours post-operation
Measured: records of the SpO2 at 12 hours post-operation
change of the SpO2 from baseline to 18 hours post-operation
records of the SpO2 at 18 hours post-operation
Measured: records of the SpO2 at 18 hours post-operation
change of the SpO2 from baseline to 48 hours post-operation
records of the SpO2 at 48 hours post-operation
Measured: records of the SpO2 at 48 hours post-operation
Secondary outcomes (3)
postoperation pain
record of postoperation pain scale at 2 hours post-operation
Measured: record of postoperation pain scale at 2 hous post operation
change of postoperation pain scale from baseline to 4 hours post-operation
record of postoperation pain scale at 4 hours post-operation
Measured: record of postoperation pain scale at 4 hours post-operation
change of postoperation pain scale from baseline to 6 hours post-operation
record of postoperation pain scale at 6 hours post-operation
Measured: Record of postoperation pain scale at 6 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory ComplicationsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi Mei Medical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Song Lin, Chi Mei Medical Hospital
- Investigators
- Yung-Song Lin, M.D., Study chair, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562691
- Sponsor's protocol ID
- CMH-09706-001
- Status last verified
- Mar 2012
- First submitted
- 21 Mar 2012
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze
- ClinicalTrials.gov ID
- NCT01562691
- Acronym / sponsor ID
- CMH-09706-001
- Keywords
- nasal packing, nasal airway, septoplasty, oxygen saturation, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chi Mei Medical HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Mar 2012 (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.
The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery.
Detailed description
Nasal packing with integrated airway had been claimed to improve body oxygenation following septal surgery. This randomized control study examined the effect of airway integrated with nasal packing, in terms of its improvement on oxygen saturation. Sixty patients with septal deviation and hypertrophic turbinate were randomized into three groups. Group 1 patients were packed with only nasopore@ after surgery. Nasopore@ with integrated airway was used for group 2 patients; and Vaseline gauze integrated with airway for group 3 patients. Hemodynamic parameters were sequentially checked. Nasal pain sensation was recorded using visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasopore only | Experimental | Procedure: NasoporePacking using nasopore without airway integrated |
| nasopore with airway integrated | Active comparator | Procedure: airway integrated Nasoporepacking using airway integrated nasopore |
| airway-integrated Vaseline gauze | Active comparator | Procedure: airway-integrated Vaseline gauzeNasal packing using airway-integrated Vaseline gauze |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis
Key exclusion criteria (1 listed)
- patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.
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 |
|---|---|---|
| NasoporeBilateral nasal packing using Nasopore without airway integrated | Procedure or surgery | Nasopore only |
| airway integrated Nasoporepost nasoseptoplasty with nasal packing using airway integrated Nasopore | Procedure or surgery | nasopore with airway integrated |
| airway-integrated Vaseline gauzepost nasal septoplasty with packing using airway-integrated Vaseline gauze | Procedure or surgery | airway-integrated Vaseline gauze |
Primary outcome
oxyhemoglobin saturation by pulse oximetry, SpO2
Time frame: SpO2 was measured 30 minutes before operation,
SpO2 was measured 30 minutes before operation using O2 saturation monitor.
change of SpO2 from baseline to 4 hours post-operation
Time frame: records of the SpO2 at 4 hours post-operation
records of the SpO2 at 4 hours post-operation
change of the SpO2 from baseline to 6 hours post-operation
Time frame: records of the SpO2 at 6 hours post-operation
records of the SpO2 at 6 hours post-operation
change of the SpO2 from baseline to 12 hours post-operation
Time frame: records of the SpO2 at 12 hours post-operation
records of the SpO2 at 12 hours post-operation
change of the SpO2 from baseline to 18 hours post-operation
Time frame: records of the SpO2 at 18 hours post-operation
records of the SpO2 at 18 hours post-operation
change of the SpO2 from baseline to 48 hours post-operation
Time frame: records of the SpO2 at 48 hours post-operation
records of the SpO2 at 48 hours post-operation
3 secondary outcomes
postoperation pain
Time frame: record of postoperation pain scale at 2 hous post operation
change of postoperation pain scale from baseline to 4 hours post-operation
Time frame: record of postoperation pain scale at 4 hours post-operation
change of postoperation pain scale from baseline to 6 hours post-operation
Time frame: Record of postoperation pain scale at 6 hours post-operation
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 26 Mar 2012.
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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.
Yung-Song Lin, M.D. study chair
Chi Mei Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nasopore, airway integrated Nasopore and airway-integrated Vaseline gauze in people with Postoperative Respiratory Complications and Pain, Postoperative., run by Chi Mei Medical Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 26 Mar 2012. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
oxyhemoglobin saturation by pulse oximetry, SpO2 (time frame: SpO2 was measured 30 minutes before operation,). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2012.