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CompletedNCT01407328Updated Apr 30, 2013

The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

An observational study in Shoulder Arthroscopic Surgery, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 20 Years to 69 Years. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Arthroscopic Surgery

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Keywords

  • shoulder arthroscopic surgery
  • respiratory discomfort
  • airway obstruction
  • restrictive pathology
  • diaphragm palsy
03

In context

Airway Obstruction

158 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.

This study's enrollment of 60 is below the median of 120 across 61 observational studies indexed under Airway Obstruction.

Browse Airway Obstruction studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing arthroscopic shoulder rotator cuff repair surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
06

What researchers measure

Primary outcomes

  1. Static compliance

    Static compliance (mL/cmH2O) before and after the arthroscopic surgery ,Static compliance = tidal volume delivered / (plateau pressure - PEEP)

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

  2. dynamic compliance

    dynamic compliance (mL/cm H2O) before and after the arthroscpic surgery ,dynamic compliance = tidal volume delivered / (peak pressure - PEEP)

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

Secondary outcomes

  1. inspiratory tidal volume

    inspiratory tidal volume (ml) before and after the arthroscpic surgery

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

  2. expiratory tidal volume

    expiratory tidal volume (ml) before and after the arthroscpic surgery

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

  3. peak inspiratory pressure

    peak inspiratory pressure (cm H2O) before and after the arthroscpic surgery

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

  4. physiologic dead space

    physiologic dead space (VD/VT) before and after arthroscopic surgery ,VD/VT = (PaCO2 - PeCO2)/PaCO2, PeCO2 = mixed expired CO2

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

  5. plateau airway pressure

    plateau airway pressure (cmH2O) before and after arthroscopic surgery

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

  6. Mean airway pressure

    Mean airway pressure (cm H2O) before and after arthroscopic surgery

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

  7. positive end expiratory pressure

    positive end expiratory pressure (cmH2O) before and after arthroscopic surgery

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

  8. inspiratory resistance

    inspiratory resistance (cmH2O/L sec) before and after arthroscopic surgery

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

  9. expiratory resistance

    expiratory resistance (cmH2O/ L sec)before and after arthroscopic surgery

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

  10. peak inspiratory flow

    peak inspiratory flow (L/min) before and after arthroscopic surgery

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

  11. peak expiratory flow

    peak expiratory flow (L/min) before and after arthroscopic surgery

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

  12. Work of breathing

    Work of breathing (J/L) before and after arthroscopic surgery

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

  13. end tidal CO2

    end tidal CO2 (mmHg) before and after arthroscopic surgery

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

  14. arterial oxygen tension

    arterial oxygen tension (mmHg) measured by arterial blood gas analysis

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

  15. arterial CO2 tension

    arterial CO2 tension (mmHg)as measured by arterial blood gas analysis

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

  16. forced vital capacity (FVC)

    forced vital capacity measured by portable spirometry

    Time frame: before and after general anesthesia, an expected average of 120 minutes

  17. forced expiratory volume for 1 second (FEV1)

    forced expiratory volume for 1 second (FEV1)measure by portable spirometry

    Time frame: before and after general anesthesia, an expected average of 120 minutes

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01407328
Responsible party
Gwak Mi Sook (Professor, Samsung Medical Center) — Principal investigator
First posted
Aug 2, 2011
Start date
Jun 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Apr 30, 2013

Study contacts

Mi Sook Gwak, M.D.,Ph.D.
principal investigator · Samsung Medical Center
Won Ho Kim, M.D.
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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