Effect of Airway Integrated Nasal Packing With Different Material

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze

Conditions
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Postoperative Respiratory Complications, Pain, Postoperative.

Intervention / Treatment
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* Procedure: Nasopore
* Procedure: airway integrated Nasopore
* Procedure: airway-integrated Vaseline gauze


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis Exclusion Criteria: patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasopore only<br>Packing using nasopore without airway integrated | Procedure: Nasopore<br>* Bilateral nasal packing using Nasopore without airway integrated<br>|
| Active Comparator: nasopore with airway integrated<br>packing using airway integrated nasopore | Procedure: airway integrated Nasopore<br>* post nasoseptoplasty with nasal packing using airway integrated Nasopore<br>|
| Active Comparator: airway-integrated Vaseline gauze<br>Nasal packing using airway-integrated Vaseline gauze | Procedure: airway-integrated Vaseline gauze<br>* post nasal septoplasty with packing using airway-integrated Vaseline gauze<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxyhemoglobin saturation by pulse oximetry, SpO2 | SpO2 was measured 30 minutes before operation using O2 saturation monitor. | 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 | 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 | 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 | 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 | 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 | records of the SpO2 at 48 hours post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperation pain | record of postoperation pain scale at 2 hours post-operation | 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 | 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 | Record of postoperation pain scale at 6 hours post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal packing, nasal airway, septoplasty, oxygen saturation, postoperative pain