The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

NCT01407328 | Completed

• 1 other identifier: 2011-06-031
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroscopic Surgery

Keywords

shoulder arthroscopic surgery; respiratory discomfort; airway obstruction; restrictive pathology; diaphragm palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (17)

• inspiratory tidal volume

  before and after arthroscopic surgery, an expected average of 80 minutes

• expiratory tidal volume

  before and after arthroscopic surgery, an expected average of 80 minutes

• peak inspiratory pressure

  before and after arthroscopic surgery, an expected average of 80 minutes

• physiologic dead space

  before and after arthroscopic surgery, an expected average of 80 minutes

• plateau airway pressure

  before and after arthroscopic surgery, an expected average of 80 minutes

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing arthroscopic shoulder rotator cuff repair surgery

You may qualify if:

• Patients undergoing arthroscopic shoulder rotator cuff repair surgery
• American society of anesthesiologist (ASA) class I or II
• Patients under 70 yrs.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mi Sook Gwak, M.D.,Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Won Ho Kim, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: August 2, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

KR (1)