Effect of Airway Integrated Nasal Packing With Different Material

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

The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Respiratory Complications; Pain, Postoperative.
• Intervention / Treatment: Procedure: Nasopore; Procedure: airway integrated Nasopore; Procedure: airway-integrated Vaseline gauze

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 70014
    • Chi Mei Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chi Mei Medical Hospital
• Investigators: Study Chair: Yung-Song Lin, M.D., Chi Mei Medical Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: postoperative pain; nasal packing; nasal airway; septoplasty; oxygen saturation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: CMH-09706-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No