Effect of Airway Integrated Nasal Packing With Different Material

Postoperative Respiratory Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562691
• Other study ID #: CMH-09706-001
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2012
• Last updated: March 23, 2012
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Chi Mei Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Pain, Postoperative.
• Postoperative Respiratory Complications

Intervention

Procedure:
• Nasopore
Bilateral nasal packing using Nasopore without airway integrated
• airway integrated Nasopore
post nasoseptoplasty with nasal packing using airway integrated Nasopore
• airway-integrated Vaseline gauze
post nasal septoplasty with packing using airway-integrated Vaseline gauze

Locations

Country	Name	City	State
Taiwan	Chi Mei Medical Center	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chi Mei Medical Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxyhemoglobin saturation by pulse oximetry, SpO2	SpO2 was measured 30 minutes before operation using O2 saturation monitor.	SpO2 was measured 30 minutes before operation,	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	postoperation pain	record of postoperation pain scale at 2 hours post-operation	record of postoperation pain scale at 2 hous post operation	No
Secondary	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	No
Secondary	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	No