Respiratory Complications After Laparoscopic Surgery

• Sponsor: Herlev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01476254
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Duration (Months): 12
• Patients Per Site: 30
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Atelectasis; Respiratory Insufficiency; Pneumonia

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Respiratory Complications After Laparoscopic Surgery
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Cholecystectomy Women scheduled for laparoscopic cholecystectomy
Hysterectomy Women scheduled for laparoscopic hysterectomy

Outcome Measures

Primary Outcome Measures

1. 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

1. Oxygenation index 2 hours after surgery [2 hours after end of surgery]

   Change in oxygenation index (PaO2/FiO2) 2 hours after surgery

2. FEV1 and FVC 2 hours after surgery [2 hours after end of surgery]

   Change in FEV1 and FVC 2 hours after surgery

3. Pulmonary shunt 2 hours after surgery [2 hours after end of surgery]

   Change in pulmonary shunt 2 hours after surgery

4. 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

5. Arterial oxygen saturation 2 hours after surgery [2 hours after surgery]

   Change in arterial oxygen saturation 2 hours after surgery

6. Respiratory frequency 2 hours after surgery [2 hours after surgery]

   Change in respiratory frequency 2 hours after surgery

7. 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%

8. 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%.

9. FEV1 and FVC 24 hours after surgery [24 hours after surgery]

   Change in FEV1 and FVC 24 hours after surgery

10. Pulmonary shunt 24 hours after surgery [24 hours after surgery]

    Change in pulmonary shunt 24 hours after surgery

11. Ventilation-perfusion ratio 24 hours after surgery [24 hours after surgery]

    Change in ventilation-perfusion ratio 24 hours after surgery

12. Arterial oxygen saturation 24 hours after surgery [24 hours after surgery]

    Change in arterial oxygen saturation 24 hours after surgery

13. Respiratory frequency 24 hours after surgery [24 hours after surgery]

    Change in respiratory frequency 24 hours after surgery

14. 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

15. 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

16. 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

17. 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

18. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesia, Herlev Hospital	Herlev		Denmark	2730
2	Department of Anesthesia, Hillerød Hospital	Hillerød		Denmark	3400

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Kathrine Staehr, Research Assistant, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT01476254
• Other Study ID Numbers: RESP-1
• First Posted: Nov 22, 2011
• Last Update Posted: Nov 20, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Anne Kathrine Staehr, Research Assistant, Herlev Hospital: Postoperative pulmonary complications; Laparoscopic surgery
• Additional relevant MeSH terms: Respiratory Insufficiency; Pulmonary Atelectasis

Study Results

No Results Posted as of Nov 20, 2012