Shoulder Arthroscopic Surgery Clinical Trial
Official title:
The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics
Verified date | April 2013 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Observational |
During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications. Furthermore, the soft tissue edema around the shoulder may extend to the thoracic cage, compress the chest and induce the respiratory distress immediately after surgery. The investigators attempt to determine the effect of shoulder arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial blood gases were measured and compared before and after the shoulder arthroscopic surgery.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 69 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Static compliance | 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 | No |
Primary | dynamic compliance | 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 | No |
Secondary | inspiratory tidal volume | inspiratory tidal volume (ml) before and after the arthroscpic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | expiratory tidal volume | expiratory tidal volume (ml) before and after the arthroscpic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | peak inspiratory pressure | peak inspiratory pressure (cm H2O) before and after the arthroscpic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | physiologic dead space | 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 | No |
Secondary | plateau airway pressure | plateau airway pressure (cmH2O) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | Mean airway pressure | Mean airway pressure (cm H2O) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | positive end expiratory pressure | positive end expiratory pressure (cmH2O) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | inspiratory resistance | inspiratory resistance (cmH2O/L sec) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | expiratory resistance | expiratory resistance (cmH2O/ L sec)before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | peak inspiratory flow | peak inspiratory flow (L/min) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | peak expiratory flow | peak expiratory flow (L/min) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | Work of breathing | Work of breathing (J/L) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | end tidal CO2 | end tidal CO2 (mmHg) before and after arthroscopic surgery | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | arterial oxygen tension | arterial oxygen tension (mmHg) measured by arterial blood gas analysis | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | arterial CO2 tension | arterial CO2 tension (mmHg)as measured by arterial blood gas analysis | before and after arthroscopic surgery, an expected average of 80 minutes | No |
Secondary | forced vital capacity (FVC) | forced vital capacity measured by portable spirometry | before and after general anesthesia, an expected average of 120 minutes | No |
Secondary | forced expiratory volume for 1 second (FEV1) | forced expiratory volume for 1 second (FEV1)measure by portable spirometry | before and after general anesthesia, an expected average of 120 minutes | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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