The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

April 28, 2013 updated by: Gwak Mi Sook, Samsung Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing arthroscopic shoulder rotator cuff repair surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
before and after arthroscopic surgery, an expected average of 80 minutes
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)
before and after arthroscopic surgery, an expected average of 80 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
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
before and after arthroscopic surgery, an expected average of 80 minutes
forced vital capacity (FVC)
Time Frame: before and after general anesthesia, an expected average of 120 minutes
forced vital capacity measured by portable spirometry
before and after general anesthesia, an expected average of 120 minutes
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
before and after general anesthesia, an expected average of 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-06-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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