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Effect of Airway Integrated Nasal Packing With Different Material

Primary Purpose

Postoperative Respiratory Complications, Pain, Postoperative.

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Nasopore

airway integrated Nasopore

airway-integrated Vaseline gauze

About this trial

This is an interventional treatment trial for Postoperative Respiratory Complications focused on measuring nasal packing, nasal airway, septoplasty, oxygen saturation, postoperative pain

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chi Mei Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Nasopore only

nasopore with airway integrated

airway-integrated Vaseline gauze

Arm Description

Packing using nasopore without airway integrated

packing using airway integrated nasopore

Nasal packing using airway-integrated Vaseline gauze

Outcomes

Primary Outcome Measures

oxyhemoglobin saturation by pulse oximetry, SpO2

SpO2 was measured 30 minutes before operation using O2 saturation monitor.

change of SpO2 from baseline to 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

change of the SpO2 from baseline to 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

change of the SpO2 from baseline to 48 hours post-operation

records of the SpO2 at 48 hours post-operation

Secondary Outcome Measures

postoperation pain

record of postoperation pain scale at 2 hours post-operation

change of postoperation pain scale from baseline to 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

Full Information

NCT ID

NCT01562691

First Posted

March 21, 2012

Last Updated

March 23, 2012

Sponsor

Chi Mei Medical Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01562691

Brief Title

Effect of Airway Integrated Nasal Packing With Different Material

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chi Mei Medical Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Respiratory Complications, Pain, Postoperative.

Keywords

nasal packing, nasal airway, septoplasty, oxygen saturation, postoperative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nasopore only

Arm Type

Experimental

Arm Description

Packing using nasopore without airway integrated

Arm Title

nasopore with airway integrated

Arm Type

Active Comparator

Arm Description

packing using airway integrated nasopore

Arm Title

airway-integrated Vaseline gauze

Arm Type

Active Comparator

Arm Description

Nasal packing using airway-integrated Vaseline gauze

Intervention Type

Procedure

Intervention Name(s)

Nasopore

Intervention Description

Bilateral nasal packing using Nasopore without airway integrated

Intervention Type

Procedure

Intervention Name(s)

airway integrated Nasopore

Intervention Description

post nasoseptoplasty with nasal packing using airway integrated Nasopore

Intervention Type

Procedure

Intervention Name(s)

airway-integrated Vaseline gauze

Intervention Description

post nasal septoplasty with packing using airway-integrated Vaseline gauze

Primary Outcome Measure Information:

Title

oxyhemoglobin saturation by pulse oximetry, SpO2

Description

SpO2 was measured 30 minutes before operation using O2 saturation monitor.

Time Frame

SpO2 was measured 30 minutes before operation,

Title

change of SpO2 from baseline to 4 hours post-operation

Description

records of the SpO2 at 4 hours post-operation

Time Frame

records of the SpO2 at 4 hours post-operation

Title

change of the SpO2 from baseline to 6 hours post-operation

Description

records of the SpO2 at 6 hours post-operation

Time Frame

records of the SpO2 at 6 hours post-operation

Title

change of the SpO2 from baseline to 12 hours post-operation

Description

records of the SpO2 at 12 hours post-operation

Time Frame

records of the SpO2 at 12 hours post-operation

Title

change of the SpO2 from baseline to 18 hours post-operation

Description

records of the SpO2 at 18 hours post-operation

Time Frame

records of the SpO2 at 18 hours post-operation

Title

change of the SpO2 from baseline to 48 hours post-operation

Description

records of the SpO2 at 48 hours post-operation

Time Frame

records of the SpO2 at 48 hours post-operation

Secondary Outcome Measure Information:

Title

postoperation pain

Description

record of postoperation pain scale at 2 hours post-operation

Time Frame

record of postoperation pain scale at 2 hous post operation

Title

change of postoperation pain scale from baseline to 4 hours post-operation

Description

record of postoperation pain scale at 4 hours post-operation

Time Frame

record of postoperation pain scale at 4 hours post-operation

Title

change of postoperation pain scale from baseline to 6 hours post-operation

Description

record of postoperation pain scale at 6 hours post-operation

Time Frame

Record of postoperation pain scale at 6 hours post-operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yung-Song Lin, M.D.

Organizational Affiliation

Chi Mei Medical Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Chi Mei Medical Center

City

Tainan

ZIP/Postal Code

70014

Country

Taiwan

12. IPD Sharing Statement

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Effect of Airway Integrated Nasal Packing With Different Material

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