NCT01562691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

March 21, 2012

Last Update Submit

March 23, 2012

Conditions

Postoperative Respiratory ComplicationsPain, Postoperative.

Keywords

nasal packingnasal airwayseptoplastyoxygen saturationpostoperative pain

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • postoperation pain

    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

  • change of postoperation pain scale from baseline to 6 hours post-operation

    Record of postoperation pain scale at 6 hours post-operation

Study Arms (3)

Nasopore only

EXPERIMENTAL

Packing using nasopore without airway integrated

Procedure: Nasopore

nasopore with airway integrated

ACTIVE COMPARATOR

packing using airway integrated nasopore

Procedure: airway integrated Nasopore

airway-integrated Vaseline gauze

ACTIVE COMPARATOR

Nasal packing using airway-integrated Vaseline gauze

Procedure: airway-integrated Vaseline gauze

Interventions

NasoporePROCEDURE

Bilateral nasal packing using Nasopore without airway integrated

Nasopore only
airway integrated NasoporePROCEDURE

post nasoseptoplasty with nasal packing using airway integrated Nasopore

nasopore with airway integrated
airway-integrated Vaseline gauzePROCEDURE

post nasal septoplasty with packing using airway-integrated Vaseline gauze

airway-integrated Vaseline gauze

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis

You may not qualify if:

  • patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Mei Medical Center

Tainan, Taiwan, 70014, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yung-Song Lin, M.D.

    Chi Mei Medical Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of department of Otolaryngology

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 26, 2012

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

TW(1)