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Respiratory Complications After Laparoscopic Surgery

Respiratory Complications After Laparoscopic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01476254
Enrollment
60
Registered
2011-11-22
Start date
2011-11-30
Completion date
2012-11-30
Last updated
2012-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Pulmonary Atelectasis, Respiratory Insufficiency

Keywords

Postoperative pulmonary complications, Laparoscopic surgery

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.

Interventions

None listed

Sponsors

Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Arterial oxygen tension 2 hours after surgery2 hours after end of surgeryChange in arterial oxygen tension 2 hours after surgery

Secondary

MeasureTime frameDescription
Connection between pulmonary shunt and need for oxygen supplement2 hours postoperatively and at discharge from the postanesthesia care unitThe 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%.
Oxygenation index 2 hours after surgery2 hours after end of surgeryChange in oxygenation index (PaO2/FiO2) 2 hours after surgery
FEV1 and FVC 2 hours after surgery2 hours after end of surgeryChange in FEV1 and FVC 2 hours after surgery
Pulmonary shunt 2 hours after surgery2 hours after end of surgeryChange in pulmonary shunt 2 hours after surgery
Ventilation-perfusion ratio 2 hours after surgery2 hours after end of surgeryChange in ventilation-perfusion ratio from baseline to 2 hours after surgery
Arterial oxygen saturation 2 hours after surgery2 hours after surgeryChange in arterial oxygen saturation 2 hours after surgery
Respiratory frequency 2 hours after surgery2 hours after surgeryChange in respiratory frequency 2 hours after surgery
Oxygen supplement at discharge from the postanesthesia care unitAt discharge from the postanesthesia care unit, which will be approximately 2 hours after surgeryThe proportion of patients who received oxygen supplement at discharge from the postanesthesia care unit in order keep arterial oxygen saturation above 93%
Pulmonary shunt 24 hours after surgery24 hours after surgeryChange in pulmonary shunt 24 hours after surgery
Ventilation-perfusion ratio 24 hours after surgery24 hours after surgeryChange in ventilation-perfusion ratio 24 hours after surgery
Arterial oxygen saturation 24 hours after surgery24 hours after surgeryChange in arterial oxygen saturation 24 hours after surgery
Respiratory frequency 24 hours after surgery24 hours after surgeryChange in respiratory frequency 24 hours after surgery
Length of stayParticipants will be followed for the duration of hospital stay, an expected average of 3 daysLength of stay at the hospital
PneumoniaParticipants will be followed for the duration of hospital stay, an expected average of 3 daysIncidence of pneumonia from surgery to discharge from hospital
Respiratory failure after surgeryParticipants will be followed for the duration of hospital stay, an expected average of 3 daysIncidence of respiratory failure from surgery to discharge from hospital
AtelectasisParticipants will be followed for the duration of hospital stay, an expected average of 3 daysIncidence of radiologically verified atelectasis from surgery to discharge from hospital
High temperatureParticipants will be followed for the duration of hospital stay, an expected average of 3 daysIncidence of a high temperature ( above 38 degrees celsius) from surgery to discharge from hospital
FEV1 and FVC 24 hours after surgery24 hours after surgeryChange in FEV1 and FVC 24 hours after surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026