Clinical trial NCT01407328: The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics
Official title: The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Arthroscopic Surgery
Keywords: shoulder arthroscopic surgery
respiratory discomfort
airway obstruction
restrictive pathology
diaphragm palsy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing arthroscopic shoulder rotator cuff repair surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Static compliance
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: dynamic compliance
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
Secondary outcomes:
measure: inspiratory tidal volume
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: expiratory tidal volume
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: peak inspiratory pressure
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: physiologic dead space
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: plateau airway pressure
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: Mean airway pressure
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: positive end expiratory pressure
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: inspiratory resistance
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: expiratory resistance
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: peak inspiratory flow
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: peak expiratory flow
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: Work of breathing
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: end tidal CO2
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: arterial oxygen tension
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: arterial CO2 tension
timeFrame: before and after arthroscopic surgery, an expected average of 80 minutes
measure: forced vital capacity (FVC)
timeFrame: before and after general anesthesia, an expected average of 120 minutes
measure: forced expiratory volume for 1 second (FEV1)
timeFrame: before and after general anesthesia, an expected average of 120 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Mi Sook Gwak, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: