Respiratory Complications After Laparoscopic Surgery

Pneumonia Clinical Trial

Official title:

Respiratory Complications After Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476254
• Other study ID #: RESP-1
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: November 19, 2012
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia
• Pulmonary Atelectasis
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Herlev Hospital	Herlev
Denmark	Department of Anesthesia, Hillerød Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial oxygen tension 2 hours after surgery	Change in arterial oxygen tension 2 hours after surgery	2 hours after end of surgery	No
Secondary	Oxygenation index 2 hours after surgery	Change in oxygenation index (PaO2/FiO2) 2 hours after surgery	2 hours after end of surgery	No
Secondary	FEV1 and FVC 2 hours after surgery	Change in FEV1 and FVC 2 hours after surgery	2 hours after end of surgery	No
Secondary	Pulmonary shunt 2 hours after surgery	Change in pulmonary shunt 2 hours after surgery	2 hours after end of surgery	No
Secondary	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	No
Secondary	Arterial oxygen saturation 2 hours after surgery	Change in arterial oxygen saturation 2 hours after surgery	2 hours after surgery	No
Secondary	Respiratory frequency 2 hours after surgery	Change in respiratory frequency 2 hours after surgery	2 hours after surgery	No
Secondary	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	No
Secondary	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	No
Secondary	FEV1 and FVC 24 hours after surgery	Change in FEV1 and FVC 24 hours after surgery	24 hours after surgery	No
Secondary	Pulmonary shunt 24 hours after surgery	Change in pulmonary shunt 24 hours after surgery	24 hours after surgery	No
Secondary	Ventilation-perfusion ratio 24 hours after surgery	Change in ventilation-perfusion ratio 24 hours after surgery	24 hours after surgery	No
Secondary	Arterial oxygen saturation 24 hours after surgery	Change in arterial oxygen saturation 24 hours after surgery	24 hours after surgery	No
Secondary	Respiratory frequency 24 hours after surgery	Change in respiratory frequency 24 hours after surgery	24 hours after surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No