Respiratory Complications After Laparoscopic Surgery

NCT ID: NCT01476254

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to describe the magnitude of respiratory complications after laparoscopic hysterectomy and cholecystectomy.

Detailed Description

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The purpose of this study is to describe change in pulmonary function and incidence of respiratory complications after laparoscopic surgery.

The investigators will include 60 women scheduled for laparoscopic hysterectomy or cholecystectomy. The investigators will measure the pulmonary function by different methods during and for 2 hours after surgery. Moreover, the incidence of respiratory complications including pneumonia, respiratory failure and radiologically verified atelectasis will be registered.

Conditions

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Pulmonary Atelectasis Respiratory Insufficiency Pneumonia

Keywords

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Postoperative pulmonary complications Laparoscopic surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cholecystectomy

Women scheduled for laparoscopic cholecystectomy

No interventions assigned to this group

Hysterectomy

Women scheduled for laparoscopic hysterectomy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women
* \> 45 years old
* Scheduled for laparoscopic cholecystectomy or laparoscopic hysterectomy

Exclusion Criteria

* Weight \< 50 kg
* Pregnant or nursing
* Cardiac failure
* Renal failure
* Inability to breath through a facial mask
* Inability to give informed consent
* Inability to keep arterial oxygen saturation above 90% without supplemental oxygen
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Kathrine Staehr

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona R Gätke, M.D. Ph.D.

Role: STUDY_CHAIR

Department of Anesthesia, Herlev Hospital, University of Copenhagen

Anne K Staehr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Herlev Hospital, University of Copenhagen

Locations

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Department of Anesthesia, Herlev Hospital

Herlev, , Denmark

Site Status

Department of Anesthesia, Hillerød Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RESP-1

Identifier Type: -

Identifier Source: org_study_id