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Completed

NCT Number: NCT01407328

The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

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.

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Key information

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Static compliance

    Time frame: 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)

  2. dynamic compliance

    Time frame: 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 outcomes

  1. inspiratory tidal volume

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

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

  2. expiratory tidal volume

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

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

  3. peak inspiratory pressure

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

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

  4. physiologic dead space

    Time frame: 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

  5. plateau airway pressure

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

    plateau airway pressure (cmH2O) before and after arthroscopic surgery

  6. Mean airway pressure

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

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

  7. positive end expiratory pressure

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

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

  8. inspiratory resistance

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

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

  9. expiratory resistance

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

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

  10. peak inspiratory flow

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

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

  11. peak expiratory flow

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

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

  12. Work of breathing

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

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

  13. end tidal CO2

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

    end tidal CO2 (mmHg) before and after arthroscopic surgery

  14. arterial oxygen tension

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

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

  15. arterial CO2 tension

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

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

  16. forced vital capacity (FVC)

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

    forced vital capacity measured by portable spirometry

  17. forced expiratory volume for 1 second (FEV1)

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

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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2011
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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