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Completed

NCT Number: NCT01562691

Effect of Airway Integrated Nasal Packing With Different Material

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

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Key information

Conditions

Postoperative Respiratory Complications Neurologic Manifestations Pain Pain, Postoperative Pain, Postoperative. Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chi Mei Medical Center

Tainan, Taiwan, 70014

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasopore

Procedure

Bilateral nasal packing using Nasopore without airway integrated

airway integrated Nasopore

Procedure

post nasoseptoplasty with nasal packing using airway integrated Nasopore

airway-integrated Vaseline gauze

Procedure

post nasal septoplasty with packing using airway-integrated Vaseline gauze

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chi Mei Medical Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2012
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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