Effect of Airway Integrated Nasal Packing With Different Material

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yung-Song Lin, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier:
NCT01562691
First received: March 21, 2012
Last updated: March 23, 2012
Last verified: March 2012

March 21, 2012
March 23, 2012
June 2009
June 2011   (final data collection date for primary outcome measure)
  • oxyhemoglobin saturation by pulse oximetry, SpO2 [ Time Frame: SpO2 was measured 30 minutes before operation, ] [ Designated as safety issue: Yes ]
    SpO2 was measured 30 minutes before operation using O2 saturation monitor.
  • change of SpO2 from baseline to 4 hours post-operation [ Time Frame: records of the SpO2 at 4 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 4 hours post-operation
  • change of the SpO2 from baseline to 6 hours post-operation [ Time Frame: records of the SpO2 at 6 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 6 hours post-operation
  • change of the SpO2 from baseline to 12 hours post-operation [ Time Frame: records of the SpO2 at 12 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 12 hours post-operation
  • change of the SpO2 from baseline to 18 hours post-operation [ Time Frame: records of the SpO2 at 18 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 18 hours post-operation
  • change of the SpO2 from baseline to 48 hours post-operation [ Time Frame: records of the SpO2 at 48 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 48 hours post-operation
Same as current
Complete list of historical versions of study NCT01562691 on ClinicalTrials.gov Archive Site
  • postoperation pain [ Time Frame: record of postoperation pain scale at 2 hous post operation ] [ Designated as safety issue: No ]
    record of postoperation pain scale at 2 hours post-operation
  • change of postoperation pain scale from baseline to 4 hours post-operation [ Time Frame: record of postoperation pain scale at 4 hours post-operation ] [ Designated as safety issue: No ]
    record of postoperation pain scale at 4 hours post-operation
  • change of postoperation pain scale from baseline to 6 hours post-operation [ Time Frame: Record of postoperation pain scale at 6 hours post-operation ] [ Designated as safety issue: No ]
    record of postoperation pain scale at 6 hours post-operation
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Postoperative Respiratory Complications
  • Pain, Postoperative.
  • Procedure: Nasopore
    Bilateral nasal packing using Nasopore without airway integrated
  • Procedure: airway integrated Nasopore
    post nasoseptoplasty with nasal packing using airway integrated Nasopore
  • Procedure: airway-integrated Vaseline gauze
    post nasal septoplasty with packing using airway-integrated Vaseline gauze
  • Experimental: Nasopore only
    Packing using nasopore without airway integrated
    Intervention: Procedure: Nasopore
  • Active Comparator: nasopore with airway integrated
    packing using airway integrated nasopore
    Intervention: Procedure: airway integrated Nasopore
  • Active Comparator: airway-integrated Vaseline gauze
    Nasal packing using airway-integrated Vaseline gauze
    Intervention: Procedure: airway-integrated Vaseline gauze
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01562691
CMH-09706-001
Yes
Yung-Song Lin, Chi Mei Medical Hospital
Chi Mei Medical Hospital
Not Provided
Study Chair: Yung-Song Lin, M.D. Chi Mei Medical Hospital
Chi Mei Medical Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP