Clinical trial NCT01476254: Respiratory Complications After Laparoscopic Surgery
Official title: Respiratory Complications After Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Atelectasis
Respiratory Insufficiency
Pneumonia
Keywords: Postoperative pulmonary complications
Laparoscopic surgery
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective laparoscopic surgery

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

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 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

Primary outcomes:
measure: Arterial oxygen tension 2 hours after surgery
timeFrame: 2 hours after end of surgery
Secondary outcomes:
measure: Oxygenation index 2 hours after surgery
timeFrame: 2 hours after end of surgery
measure: FEV1 and FVC 2 hours after surgery
timeFrame: 2 hours after end of surgery
measure: Pulmonary shunt 2 hours after surgery
timeFrame: 2 hours after end of surgery
measure: Ventilation-perfusion ratio 2 hours after surgery
timeFrame: 2 hours after end of surgery
measure: Arterial oxygen saturation 2 hours after surgery
timeFrame: 2 hours after surgery
measure: Respiratory frequency 2 hours after surgery
timeFrame: 2 hours after surgery
measure: Oxygen supplement at discharge from the postanesthesia care unit
timeFrame: At discharge from the postanesthesia care unit, which will be approximately 2 hours after surgery
measure: Connection between pulmonary shunt and need for oxygen supplement
timeFrame: 2 hours postoperatively and at discharge from the postanesthesia care unit
measure: FEV1 and FVC 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Pulmonary shunt 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Ventilation-perfusion ratio 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Arterial oxygen saturation 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Respiratory frequency 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Pneumonia
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Respiratory failure after surgery
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Atelectasis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: High temperature
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Anesthesia, Herlev Hospital
city: Hillerød
country: Denmark
facility: Department of Anesthesia, Hillerød Hospital
Study officials:
affiliation: Department of Anesthesia, Herlev Hospital, University of Copenhagen
name: Mona R Gätke, M.D. Ph.D.
role: STUDY_CHAIR
affiliation: Department of Anesthesia, Herlev Hospital, University of Copenhagen
name: Anne K Staehr, M.D.
role: PRINCIPAL_INVESTIGATOR
References: