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Completed

NCT Number: NCT01476254

Respiratory Complications After Laparoscopic Surgery

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

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Key information

Conditions

Pulmonary Atelectasis Infections Lung Diseases Pneumonia Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesia, Herlev Hospital, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Arterial oxygen tension 2 hours after surgery

    Time frame: 2 hours after end of surgery

    Change in arterial oxygen tension 2 hours after surgery

Secondary outcomes

  1. Oxygenation index 2 hours after surgery

    Time frame: 2 hours after end of surgery

    Change in oxygenation index (PaO2/FiO2) 2 hours after surgery

  2. FEV1 and FVC 2 hours after surgery

    Time frame: 2 hours after end of surgery

    Change in FEV1 and FVC 2 hours after surgery

  3. Pulmonary shunt 2 hours after surgery

    Time frame: 2 hours after end of surgery

    Change in pulmonary shunt 2 hours after surgery

  4. Ventilation-perfusion ratio 2 hours after surgery

    Time frame: 2 hours after end of surgery

    Change in ventilation-perfusion ratio from baseline to 2 hours after surgery

  5. Arterial oxygen saturation 2 hours after surgery

    Time frame: 2 hours after surgery

    Change in arterial oxygen saturation 2 hours after surgery

  6. Respiratory frequency 2 hours after surgery

    Time frame: 2 hours after surgery

    Change in respiratory frequency 2 hours after surgery

  7. 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

    The proportion of patients who received oxygen supplement at discharge from the postanesthesia care unit in order keep arterial oxygen saturation above 93%

  8. Connection between pulmonary shunt and need for oxygen supplement

    Time frame: 2 hours postoperatively and at discharge from the postanesthesia care unit

    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%.

  9. FEV1 and FVC 24 hours after surgery

    Time frame: 24 hours after surgery

    Change in FEV1 and FVC 24 hours after surgery

  10. Pulmonary shunt 24 hours after surgery

    Time frame: 24 hours after surgery

    Change in pulmonary shunt 24 hours after surgery

  11. Ventilation-perfusion ratio 24 hours after surgery

    Time frame: 24 hours after surgery

    Change in ventilation-perfusion ratio 24 hours after surgery

  12. Arterial oxygen saturation 24 hours after surgery

    Time frame: 24 hours after surgery

    Change in arterial oxygen saturation 24 hours after surgery

  13. Respiratory frequency 24 hours after surgery

    Time frame: 24 hours after surgery

    Change in respiratory frequency 24 hours after surgery

  14. Length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Length of stay at the hospital

  15. Pneumonia

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Incidence of pneumonia from surgery to discharge from hospital

  16. Respiratory failure after surgery

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Incidence of respiratory failure from surgery to discharge from hospital

  17. Atelectasis

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Incidence of radiologically verified atelectasis from surgery to discharge from hospital

  18. High temperature

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Incidence of a high temperature ( above 38 degrees celsius) from surgery to discharge from hospital

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2011
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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