Respiratory Complications After Laparoscopic Surgery

Study Overview
=================
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.

Official Title
-----------------
Respiratory Complications After Laparoscopic Surgery

Conditions
-----------------
Pulmonary Atelectasis, Respiratory Insufficiency, Pneumonia

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cholecystectomy<br>Women scheduled for laparoscopic cholecystectomy | |
| Hysterectomy<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pulmonary complications, Laparoscopic surgery