Respiratory Complications After Laparoscopic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Kathrine Staehr, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01476254
First received: November 15, 2011
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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


Condition
Pulmonary Atelectasis
Respiratory Insufficiency
Pneumonia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Respiratory Complications After Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Arterial oxygen tension 2 hours after surgery [ Time Frame: 2 hours after end of surgery ] [ Designated as safety issue: No ]
    Change in arterial oxygen tension 2 hours after surgery


Secondary Outcome Measures:
  • Oxygenation index 2 hours after surgery [ Time Frame: 2 hours after end of surgery ] [ Designated as safety issue: No ]
    Change in oxygenation index (PaO2/FiO2) 2 hours after surgery

  • FEV1 and FVC 2 hours after surgery [ Time Frame: 2 hours after end of surgery ] [ Designated as safety issue: No ]
    Change in FEV1 and FVC 2 hours after surgery

  • Pulmonary shunt 2 hours after surgery [ Time Frame: 2 hours after end of surgery ] [ Designated as safety issue: No ]
    Change in pulmonary shunt 2 hours after surgery

  • Ventilation-perfusion ratio 2 hours after surgery [ Time Frame: 2 hours after end of surgery ] [ Designated as safety issue: No ]
    Change in ventilation-perfusion ratio from baseline to 2 hours after surgery

  • Arterial oxygen saturation 2 hours after surgery [ Time Frame: 2 hours after surgery ] [ Designated as safety issue: No ]
    Change in arterial oxygen saturation 2 hours after surgery

  • Respiratory frequency 2 hours after surgery [ Time Frame: 2 hours after surgery ] [ Designated as safety issue: No ]
    Change in respiratory frequency 2 hours after surgery

  • Oxygen supplement at discharge from the postanesthesia care unit [ Time Frame: At discharge from the postanesthesia care unit, which will be approximately 2 hours after surgery ] [ Designated as safety issue: No ]
    The proportion of patients who received oxygen supplement at discharge from the postanesthesia care unit in order keep arterial oxygen saturation above 93%

  • Connection between pulmonary shunt and need for oxygen supplement [ Time Frame: 2 hours postoperatively and at discharge from the postanesthesia care unit ] [ Designated as safety issue: No ]
    The connection between pulmonary shunt 2 hours after surgery and need for oxygen supplement at discharge from the postanesthesia department in order to keep peripheral oxygen saturation above 93%.

  • FEV1 and FVC 24 hours after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    Change in FEV1 and FVC 24 hours after surgery

  • Pulmonary shunt 24 hours after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    Change in pulmonary shunt 24 hours after surgery

  • Ventilation-perfusion ratio 24 hours after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    Change in ventilation-perfusion ratio 24 hours after surgery

  • Arterial oxygen saturation 24 hours after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    Change in arterial oxygen saturation 24 hours after surgery

  • Respiratory frequency 24 hours after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    Change in respiratory frequency 24 hours after surgery

  • Length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Length of stay at the hospital

  • Pneumonia [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Incidence of pneumonia from surgery to discharge from hospital

  • Respiratory failure after surgery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Incidence of respiratory failure from surgery to discharge from hospital

  • Atelectasis [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Incidence of radiologically verified atelectasis from surgery to discharge from hospital

  • High temperature [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Incidence of a high temperature ( above 38 degrees celsius) from surgery to discharge from hospital


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cholecystectomy
Women scheduled for laparoscopic cholecystectomy
Hysterectomy
Women scheduled for laparoscopic hysterectomy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for elective laparoscopic surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476254

Locations
Denmark
Department of Anesthesia, Herlev Hospital
Herlev, Denmark, 2730
Department of Anesthesia, Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Herlev Hospital
Investigators
Study Chair: Mona R Gätke, M.D. Ph.D. Department of Anesthesia, Herlev Hospital, University of Copenhagen
Principal Investigator: Anne K Staehr, M.D. Department of Anesthesia, Herlev Hospital, University of Copenhagen
  More Information

No publications provided

Responsible Party: Anne Kathrine Staehr, Research Assistant, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01476254     History of Changes
Other Study ID Numbers: RESP-1
Study First Received: November 15, 2011
Last Updated: November 19, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
Postoperative pulmonary complications
Laparoscopic surgery

Additional relevant MeSH terms:
Pulmonary Atelectasis
Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders

ClinicalTrials.gov processed this record on July 23, 2014