Effect of Airway Integrated Nasal Packing With Different Material

NCT ID: NCT01562691

Last Updated: 2012-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

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.

Conditions

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Postoperative Respiratory Complications Pain, Postoperative.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nasopore only

Packing using nasopore without airway integrated

Group Type EXPERIMENTAL

Nasopore

Intervention Type PROCEDURE

Bilateral nasal packing using Nasopore without airway integrated

nasopore with airway integrated

packing using airway integrated nasopore

Group Type ACTIVE_COMPARATOR

airway integrated Nasopore

Intervention Type PROCEDURE

post nasoseptoplasty with nasal packing using airway integrated Nasopore

airway-integrated Vaseline gauze

Nasal packing using airway-integrated Vaseline gauze

Group Type ACTIVE_COMPARATOR

airway-integrated Vaseline gauze

Intervention Type PROCEDURE

post nasal septoplasty with packing using airway-integrated Vaseline gauze

Interventions

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Nasopore

Bilateral nasal packing using Nasopore without airway integrated

Intervention Type PROCEDURE

airway integrated Nasopore

post nasoseptoplasty with nasal packing using airway integrated Nasopore

Intervention Type PROCEDURE

airway-integrated Vaseline gauze

post nasal septoplasty with packing using airway-integrated Vaseline gauze

Intervention Type PROCEDURE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chi Mei Medical Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yung-Song Lin

Chairman of department of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yung-Song Lin, M.D.

Role: STUDY_CHAIR

Chi Mei Medical Hospital

Locations

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Chi Mei Medical Center

Tainan City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMH-09706-001

Identifier Type: -

Identifier Source: org_study_id

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