Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor

NCT ID: NCT01082575

Last Updated: 2014-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-08-31

Brief Summary

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The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.

Detailed Description

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No further details necessary or available.

Conditions

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Sleep Disordered Breathing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Major Surgery

Oxygen Monitoring

Oxygen Monitoring

Intervention Type DEVICE

No intervention

Interventions

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Oxygen Monitoring

No intervention

Intervention Type DEVICE

Other Intervention Names

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Nellcor Pulse Oximeter N600X

Eligibility Criteria

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Inclusion Criteria

* Age of 18 years or older
* Discharge from the post-anesthesia care unit (PACU) to the GCF after any of the following major surgeries: bariatric surgery, major orthopedic surgery (e.g., total hip replacement), major general surgery (e.g., bowel resections, open cholecystectomy), and major gynecological surgery (e.g., radical hysterectomy)

Exclusion Criteria

* Pre-existing central neurological disease, including but not limited to recent traumatic brain injury, stroke, and neurodegenerative disease
* Ongoing use of mechanical ventilation or continuous positive airway pressure in the GCF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Mecca, MD

Role: STUDY_CHAIR

Medtronic - MITG

Locations

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Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Texas Health Research & Education Institute

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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COV-MO-PO-A109

Identifier Type: -

Identifier Source: org_study_id

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