- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407328
The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing arthroscopic shoulder rotator cuff repair surgery
- American society of anesthesiologist (ASA) class I or II
- Patients under 70 yrs.
Exclusion Criteria:
- Patients older than 70 yrs,
- Patients with anatomical derangement of upper airway,
- Patients with pulmonary or cardiac disease,
- Patients with a history of laryngeal or tracheal surgery or hemodynamic instability
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static compliance
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
Static compliance (mL/cmH2O) before and after the arthroscopic surgery ,Static compliance = tidal volume delivered / (plateau pressure - PEEP) |
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
dynamic compliance
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
dynamic compliance (mL/cm H2O) before and after the arthroscpic surgery ,dynamic compliance = tidal volume delivered / (peak pressure - PEEP) |
before and after arthroscopic surgery, an expected average of 80 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inspiratory tidal volume
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
inspiratory tidal volume (ml) before and after the arthroscpic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
expiratory tidal volume
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
expiratory tidal volume (ml) before and after the arthroscpic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
peak inspiratory pressure
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
peak inspiratory pressure (cm H2O) before and after the arthroscpic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
physiologic dead space
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
physiologic dead space (VD/VT) before and after arthroscopic surgery ,VD/VT = (PaCO2 - PeCO2)/PaCO2, PeCO2 = mixed expired CO2 |
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
plateau airway pressure
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
plateau airway pressure (cmH2O) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
Mean airway pressure
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
Mean airway pressure (cm H2O) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
positive end expiratory pressure
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
positive end expiratory pressure (cmH2O) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
inspiratory resistance
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
inspiratory resistance (cmH2O/L sec) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
expiratory resistance
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
expiratory resistance (cmH2O/ L sec)before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
peak inspiratory flow
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
peak inspiratory flow (L/min) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
peak expiratory flow
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
peak expiratory flow (L/min) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
Work of breathing
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
Work of breathing (J/L) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
end tidal CO2
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
end tidal CO2 (mmHg) before and after arthroscopic surgery
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
arterial oxygen tension
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
arterial oxygen tension (mmHg) measured by arterial blood gas analysis
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
arterial CO2 tension
Time Frame: before and after arthroscopic surgery, an expected average of 80 minutes
|
arterial CO2 tension (mmHg)as measured by arterial blood gas analysis
|
before and after arthroscopic surgery, an expected average of 80 minutes
|
|
forced vital capacity (FVC)
Time Frame: before and after general anesthesia, an expected average of 120 minutes
|
forced vital capacity measured by portable spirometry
|
before and after general anesthesia, an expected average of 120 minutes
|
|
forced expiratory volume for 1 second (FEV1)
Time Frame: before and after general anesthesia, an expected average of 120 minutes
|
forced expiratory volume for 1 second (FEV1)measure by portable spirometry
|
before and after general anesthesia, an expected average of 120 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2011-06-031
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