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Shoulder Arthroscopic SurgeryNCT01407328

The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

An observational study of Shoulder Arthroscopic Surgery, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 69 years
Conditions the study is for
Shoulder Arthroscopic Surgery
How many people
60 participants
Where
1 siteSouth Korea
Study dates
Jun 2011to Apr 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients undergoing arthroscopic shoulder rotator cuff repair surgery

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

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.

Keywords
shoulder arthroscopic surgery, respiratory discomfort, airway obstruction, restrictive pathology, diaphragm palsy
Medical subject headings
Airway Obstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Static compliance

    Static compliance (mL/cmH2O) before and after the arthroscopic surgery

    ,Static compliance = tidal volume delivered / (plateau pressure - PEEP)

    Measured: 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)

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

Secondary outcomes (17)

  1. inspiratory tidal volume

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

    Measured: 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

    Measured: 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

    Measured: 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

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

  5. plateau airway pressure

    plateau airway pressure (cmH2O) before and after arthroscopic surgery

    Measured: 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

    Measured: 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

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

  8. inspiratory resistance

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

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

  9. expiratory resistance

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

    Measured: 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

    Measured: 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

    Measured: 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

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

  13. end tidal CO2

    end tidal CO2 (mmHg) before and after arthroscopic surgery

    Measured: 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

    Measured: 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

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

  16. forced vital capacity (FVC)

    forced vital capacity measured by portable spirometry

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407328
Sponsor's protocol ID
2011-06-031
Status last verified
Apr 2013
First submitted
5 Jul 2011
Last updated
30 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Shoulder Arthroscopic Surgery, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static compliance (time frame: before and after arthroscopic surgery, an expected average of 80 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.

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