The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

Shoulder Arthroscopic Surgery Clinical Trial

Official title:

The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407328
• Other study ID #: 2011-06-031
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: April 28, 2013
• Start date: June 2011
• Est. completion date: April 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shoulder Arthroscopic Surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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