Effect of Airway Integrated Nasal Packing With Different Material

• ClinicalTrials.gov Identifier: NCT01562691
• Recruitment Status: Completed
• First Posted: March 26, 2012
• Last Update Posted: March 26, 2012
• Sponsor: Chi Mei Medical Hospital
• Information provided by (Responsible Party): Yung-Song Lin, Chi Mei Medical Hospital

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Respiratory Complications; Pain, Postoperative.	Procedure: Nasopore; Procedure: airway integrated Nasopore; Procedure: airway-integrated Vaseline gauze	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze
• Study Start Date: June 2009
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. oxyhemoglobin saturation by pulse oximetry, SpO2 [ Time Frame: SpO2 was measured 30 minutes before operation, ]
   SpO2 was measured 30 minutes before operation using O2 saturation monitor.
2. change of SpO2 from baseline to 4 hours post-operation [ Time Frame: records of the SpO2 at 4 hours post-operation ]
   records of the SpO2 at 4 hours post-operation
3. change of the SpO2 from baseline to 6 hours post-operation [ Time Frame: records of the SpO2 at 6 hours post-operation ]
   records of the SpO2 at 6 hours post-operation
4. change of the SpO2 from baseline to 12 hours post-operation [ Time Frame: records of the SpO2 at 12 hours post-operation ]
   records of the SpO2 at 12 hours post-operation
5. change of the SpO2 from baseline to 18 hours post-operation [ Time Frame: records of the SpO2 at 18 hours post-operation ]
   records of the SpO2 at 18 hours post-operation
6. change of the SpO2 from baseline to 48 hours post-operation [ Time Frame: records of the SpO2 at 48 hours post-operation ]
   records of the SpO2 at 48 hours post-operation

Secondary Outcome Measures :

1. postoperation pain [ Time Frame: record of postoperation pain scale at 2 hous post operation ]
   record of postoperation pain scale at 2 hours post-operation
2. change of postoperation pain scale from baseline to 4 hours post-operation [ Time Frame: record of postoperation pain scale at 4 hours post-operation ]
   record of postoperation pain scale at 4 hours post-operation
3. change of postoperation pain scale from baseline to 6 hours post-operation [ Time Frame: Record of postoperation pain scale at 6 hours post-operation ]
   record of postoperation pain scale at 6 hours post-operation

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Taiwan

Chi Mei Medical Center

Tainan, Taiwan, 70014

Sponsors and Collaborators

Chi Mei Medical Hospital

Investigators

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

More Information

• Responsible Party: Yung-Song Lin, Chairman of department of Otolaryngology, Chi Mei Medical Hospital
• ClinicalTrials.gov Identifier: NCT01562691
• Other Study ID Numbers: CMH-09706-001
• First Posted: March 26, 2012
• Last Update Posted: March 26, 2012
• Last Verified: March 2012

Keywords provided by Yung-Song Lin, Chi Mei Medical Hospital:

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

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Petrolatum; Emollients; Dermatologic Agents