Respiratory Complications After Laparoscopic Surgery

Completed

• Conditions: Pulmonary Atelectasis; Respiratory Insufficiency; Pneumonia

• Registration Number: NCT01476254
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-19
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial oxygen tension 2 hours after surgery	2 hours after end of surgery	Change in arterial oxygen tension 2 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Pneumonia	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
Oxygenation index 2 hours after surgery	2 hours after end of surgery	Change in oxygenation index (PaO2/FiO2) 2 hours after surgery
FEV1 and FVC 2 hours after surgery	2 hours after end of surgery	Change in FEV1 and FVC 2 hours after surgery
Pulmonary shunt 2 hours after surgery	2 hours after end of surgery	Change in pulmonary shunt 2 hours after surgery
Ventilation-perfusion ratio 2 hours after surgery	2 hours after end of surgery	Change in ventilation-perfusion ratio from baseline to 2 hours after surgery
Arterial oxygen saturation 2 hours after surgery	2 hours after surgery	Change in arterial oxygen saturation 2 hours after surgery
Respiratory frequency 2 hours after surgery	2 hours after surgery	Change in respiratory frequency 2 hours after surgery
Oxygen supplement at discharge from the postanesthesia care unit	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%
Connection between pulmonary shunt and need for oxygen supplement	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%.
FEV1 and FVC 24 hours after surgery	24 hours after surgery	Change in FEV1 and FVC 24 hours after surgery
Pulmonary shunt 24 hours after surgery	24 hours after surgery	Change in pulmonary shunt 24 hours after surgery
Ventilation-perfusion ratio 24 hours after surgery	24 hours after surgery	Change in ventilation-perfusion ratio 24 hours after surgery
Arterial oxygen saturation 24 hours after surgery	24 hours after surgery	Change in arterial oxygen saturation 24 hours after surgery
Respiratory frequency 24 hours after surgery	24 hours after surgery	Change in respiratory frequency 24 hours after surgery
Length of stay	Participants will be followed for the duration of hospital stay, an expected average of 3 days	Length of stay at the hospital
Respiratory failure after surgery	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
Atelectasis	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
High temperature	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

Trial Locations

Locations (2)

Department of Anesthesia, Herlev Hospital; 🇩🇰 Herlev, Denmark

Department of Anesthesia, Hillerød Hospital; 🇩🇰 Hillerød, Denmark