Effect of Airway Integrated Nasal Packing With Different Material

Phase 4

Completed

• Conditions: Postoperative Respiratory Complications; Pain, Postoperative.
• Interventions: Procedure: Nasopore; Procedure: airway integrated Nasopore; Procedure: airway-integrated Vaseline gauze

• Registration Number: NCT01562691
• Lead Sponsor: Chi Mei Medical Hospital

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-23
• Last Update Submitted: 2012-03-23
• Study First Posted: 2012-03-26
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Nasopore only	Nasopore	Packing using nasopore without airway integrated
nasopore with airway integrated	airway integrated Nasopore	packing using airway integrated nasopore
airway-integrated Vaseline gauze	airway-integrated Vaseline gauze	Nasal packing using airway-integrated Vaseline gauze

Primary Outcome Measures

Name	Time	Method
oxyhemoglobin saturation by pulse oximetry, SpO2	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	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

Name	Time	Method
postoperation pain	record of postoperation pain scale at 2 hous post operation	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	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

Trial Locations

Locations (1)

Chi Mei Medical Center; 🇨🇳 Tainan, Taiwan