The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

Completed

• Conditions: Shoulder Arthroscopic Surgery

• Registration Number: NCT01407328
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Currently, most shoulder surgeries are performed with arthroscopy. The advantages of shoulder arthroscopic surgery are decreased blood loss due to minimal incision for scope, a reduced operation time, minimization of surgical stress, and rapid recovery time after surgery. 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. From these facts, the mechanism of respiratory discomfort after shoulder arthroscopic surgery may be because the upper airway obstruction or restrictive pathology due to direct compression of thoracic cage by the soft tissue edema. There have been no studies on the respiratory effect of shoulder arthroscopic surgery. We have observed frequent and severe respiratory discomfort after the shoulder arthroscopic surgery. Therefore, in this study we 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-31
• Study First Posted: 2011-08-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-28
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Static compliance	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)
dynamic compliance	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)

Secondary Outcome Measures

Name	Time	Method
expiratory resistance	before and after arthroscopic surgery, an expected average of 80 minutes	expiratory resistance (cmH2O/ L sec)before and after arthroscopic surgery
inspiratory tidal volume	before and after arthroscopic surgery, an expected average of 80 minutes	inspiratory tidal volume (ml) before and after the arthroscpic surgery
expiratory tidal volume	before and after arthroscopic surgery, an expected average of 80 minutes	expiratory tidal volume (ml) before and after the arthroscpic surgery
peak inspiratory pressure	before and after arthroscopic surgery, an expected average of 80 minutes	peak inspiratory pressure (cm H2O) before and after the arthroscpic surgery
physiologic dead space	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
plateau airway pressure	before and after arthroscopic surgery, an expected average of 80 minutes	plateau airway pressure (cmH2O) before and after arthroscopic surgery
Mean airway pressure	before and after arthroscopic surgery, an expected average of 80 minutes	Mean airway pressure (cm H2O) before and after arthroscopic surgery
positive end expiratory pressure	before and after arthroscopic surgery, an expected average of 80 minutes	positive end expiratory pressure (cmH2O) before and after arthroscopic surgery
inspiratory resistance	before and after arthroscopic surgery, an expected average of 80 minutes	inspiratory resistance (cmH2O/L sec) before and after arthroscopic surgery
peak inspiratory flow	before and after arthroscopic surgery, an expected average of 80 minutes	peak inspiratory flow (L/min) before and after arthroscopic surgery
peak expiratory flow	before and after arthroscopic surgery, an expected average of 80 minutes	peak expiratory flow (L/min) before and after arthroscopic surgery
Work of breathing	before and after arthroscopic surgery, an expected average of 80 minutes	Work of breathing (J/L) before and after arthroscopic surgery
end tidal CO2	before and after arthroscopic surgery, an expected average of 80 minutes	end tidal CO2 (mmHg) before and after arthroscopic surgery
arterial oxygen tension	before and after arthroscopic surgery, an expected average of 80 minutes	arterial oxygen tension (mmHg) measured by arterial blood gas analysis
arterial CO2 tension	before and after arthroscopic surgery, an expected average of 80 minutes	arterial CO2 tension (mmHg)as measured by arterial blood gas analysis
forced vital capacity (FVC)	before and after general anesthesia, an expected average of 120 minutes	forced vital capacity measured by portable spirometry
forced expiratory volume for 1 second (FEV1)	before and after general anesthesia, an expected average of 120 minutes	forced expiratory volume for 1 second (FEV1)measure by portable spirometry

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of