Clinical trial NCT01562691: Effect of Airway Integrated Nasal Packing With Different Material
Official title: Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Respiratory Complications
Pain, Postoperative.
Keywords: nasal packing
nasal airway
septoplasty
oxygen saturation
postoperative pain
Lead sponsor: Chi Mei Medical Hospital
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: oxyhemoglobin saturation by pulse oximetry, SpO2
timeFrame: SpO2 was measured 30 minutes before operation,
measure: change of SpO2 from baseline to 4 hours post-operation
timeFrame: records of the SpO2 at 4 hours post-operation
measure: change of the SpO2 from baseline to 6 hours post-operation
timeFrame: records of the SpO2 at 6 hours post-operation
measure: change of the SpO2 from baseline to 12 hours post-operation
timeFrame: records of the SpO2 at 12 hours post-operation
measure: change of the SpO2 from baseline to 18 hours post-operation
timeFrame: records of the SpO2 at 18 hours post-operation
measure: change of the SpO2 from baseline to 48 hours post-operation
timeFrame: records of the SpO2 at 48 hours post-operation
Secondary outcomes:
measure: postoperation pain
timeFrame: record of postoperation pain scale at 2 hous post operation
measure: change of postoperation pain scale from baseline to 4 hours post-operation
timeFrame: record of postoperation pain scale at 4 hours post-operation
measure: change of postoperation pain scale from baseline to 6 hours post-operation
timeFrame: Record of postoperation pain scale at 6 hours post-operation
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
Study officials:
affiliation: Chi Mei Medical Hospital
name: Yung-Song Lin, M.D.
role: STUDY_CHAIR
References: