Respiratory Complications After Laparoscopic Surgery

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

Study Overview

• Status: Completed
• Conditions: Pneumonia; Pulmonary Atelectasis; Respiratory Insufficiency

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Anesthesia, Herlev Hospital
  • Hillerød, Denmark, 3400
    • Department of Anesthesia, Hillerød Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective laparoscopic surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cholecystectomy; Women scheduled for laparoscopic cholecystectomy
Hysterectomy; Women scheduled for laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygen tension 2 hours after surgery	Change in arterial oxygen tension 2 hours after surgery	2 hours after end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation index 2 hours after surgery	Change in oxygenation index (PaO2/FiO2) 2 hours after surgery	2 hours after end of surgery
FEV1 and FVC 2 hours after surgery	Change in FEV1 and FVC 2 hours after surgery	2 hours after end of surgery
Pulmonary shunt 2 hours after surgery	Change in pulmonary shunt 2 hours after surgery	2 hours after end of surgery
Ventilation-perfusion ratio 2 hours after surgery	Change in ventilation-perfusion ratio from baseline to 2 hours after surgery	2 hours after end of surgery
Arterial oxygen saturation 2 hours after surgery	Change in arterial oxygen saturation 2 hours after surgery	2 hours after surgery
Respiratory frequency 2 hours after surgery	Change in respiratory frequency 2 hours after surgery	2 hours after surgery
Oxygen supplement at discharge from the postanesthesia care unit	The proportion of patients who received oxygen supplement at discharge from the postanesthesia care unit in order keep arterial oxygen saturation above 93%	At discharge from the postanesthesia care unit, which will be approximately 2 hours after surgery
Connection between pulmonary shunt and need for oxygen supplement	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%.	2 hours postoperatively and at discharge from the postanesthesia care unit
FEV1 and FVC 24 hours after surgery	Change in FEV1 and FVC 24 hours after surgery	24 hours after surgery
Pulmonary shunt 24 hours after surgery	Change in pulmonary shunt 24 hours after surgery	24 hours after surgery
Ventilation-perfusion ratio 24 hours after surgery	Change in ventilation-perfusion ratio 24 hours after surgery	24 hours after surgery
Arterial oxygen saturation 24 hours after surgery	Change in arterial oxygen saturation 24 hours after surgery	24 hours after surgery
Respiratory frequency 24 hours after surgery	Change in respiratory frequency 24 hours after surgery	24 hours after surgery
Length of stay	Length of stay at the hospital	Participants will be followed for the duration of hospital stay, an expected average of 3 days
Pneumonia	Incidence of pneumonia from surgery to discharge from hospital	Participants will be followed for the duration of hospital stay, an expected average of 3 days
Respiratory failure after surgery	Incidence of respiratory failure from surgery to discharge from hospital	Participants will be followed for the duration of hospital stay, an expected average of 3 days
Atelectasis	Incidence of radiologically verified atelectasis from surgery to discharge from hospital	Participants will be followed for the duration of hospital stay, an expected average of 3 days
High temperature	Incidence of a high temperature ( above 38 degrees celsius) from surgery to discharge from hospital	Participants will be followed for the duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 19, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Postoperative pulmonary complications
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Pulmonary Atelectasis; Respiratory Insufficiency
• Other Study ID Numbers: RESP-1