Pulmonary AtelectasisNCT01476254
Respiratory Complications After Laparoscopic Surgery
An observational study of Pulmonary Atelectasis and Respiratory Insufficiency, run by Herlev Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to describe the magnitude of respiratory complications after laparoscopic hysterectomy and cholecystectomy. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Pulmonary Atelectasis, Respiratory Insufficiency, Pneumonia
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective laparoscopic surgery
Who may be able to join
- Women
- > 45 years old
- Scheduled for laparoscopic cholecystectomy or laparoscopic hysterectomy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Anesthesia, Herlev Hospital
Herlev, 2730
Department of Anesthesia, Hillerød Hospital
Hillerød, 3400
About this study
The purpose of this study is to describe the magnitude of respiratory complications after laparoscopic hysterectomy and cholecystectomy.
Read the 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.
- Conditions
- Pulmonary Atelectasis, Respiratory Insufficiency, Pneumonia
- Keywords
- Postoperative pulmonary complications, Laparoscopic surgery
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Insufficiency, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy | Women scheduled for laparoscopic cholecystectomy | |
| Hysterectomy | Women scheduled for laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen tension 2 hours after surgery
Change in arterial oxygen tension 2 hours after surgery
Measured: 2 hours after end of surgery
Secondary outcomes (18)
Oxygenation index 2 hours after surgery
Change in oxygenation index (PaO2/FiO2) 2 hours after surgery
Measured: 2 hours after end of surgery
FEV1 and FVC 2 hours after surgery
Change in FEV1 and FVC 2 hours after surgery
Measured: 2 hours after end of surgery
Pulmonary shunt 2 hours after surgery
Change in pulmonary shunt 2 hours after surgery
Measured: 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
Measured: 2 hours after end of surgery
Arterial oxygen saturation 2 hours after surgery
Change in arterial oxygen saturation 2 hours after surgery
Measured: 2 hours after surgery
Respiratory frequency 2 hours after surgery
Change in respiratory frequency 2 hours after surgery
Measured: 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%
Measured: 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%.
Measured: 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
Measured: 24 hours after surgery
Pulmonary shunt 24 hours after surgery
Change in pulmonary shunt 24 hours after surgery
Measured: 24 hours after surgery
Ventilation-perfusion ratio 24 hours after surgery
Change in ventilation-perfusion ratio 24 hours after surgery
Measured: 24 hours after surgery
Arterial oxygen saturation 24 hours after surgery
Change in arterial oxygen saturation 24 hours after surgery
Measured: 24 hours after surgery
Respiratory frequency 24 hours after surgery
Change in respiratory frequency 24 hours after surgery
Measured: 24 hours after surgery
Length of stay
Length of stay at the hospital
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kathrine Staehr, Herlev Hospital
- Investigators
- Mona R Gätke, M.D. Ph.D., Study chair, Department of Anesthesia, Herlev Hospital, University of CopenhagenAnne K Staehr, M.D., Principal investigator, Department of Anesthesia, Herlev Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476254
- Sponsor's protocol ID
- RESP-1
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Complications After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01476254
- Acronym / sponsor ID
- RESP-1
- Conditions
- Pulmonary Atelectasis, Respiratory Insufficiency, Pneumonia
- Keywords
- Postoperative pulmonary complications, Laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy | – | –Women scheduled for laparoscopic cholecystectomy |
| Hysterectomy | – | –Women scheduled for laparoscopic hysterectomy |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective laparoscopic surgery
Key inclusion criteria (3 listed)
- Women
- > 45 years old
- Scheduled for laparoscopic cholecystectomy or laparoscopic hysterectomy
Key exclusion criteria (7 listed)
- Weight < 50 kg
- Pregnant or nursing
- Cardiac failure
- Renal failure
- Inability to breath through a facial mask
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial oxygen tension 2 hours after surgery
Time frame: 2 hours after end of surgery
Change in arterial oxygen tension 2 hours after surgery
18 secondary outcomes
Oxygenation index 2 hours after surgery
Time frame: 2 hours after end of surgery
FEV1 and FVC 2 hours after surgery
Time frame: 2 hours after end of surgery
Pulmonary shunt 2 hours after surgery
Time frame: 2 hours after end of surgery
Ventilation-perfusion ratio 2 hours after surgery
Time frame: 2 hours after end of surgery
Arterial oxygen saturation 2 hours after surgery
Time frame: 2 hours after surgery
Respiratory frequency 2 hours after surgery
Time frame: 2 hours after surgery
Oxygen supplement at discharge from the postanesthesia care unit
Time frame: At discharge from the postanesthesia care unit, which will be approximately 2 hours after surgery
Connection between pulmonary shunt and need for oxygen supplement
Time frame: 2 hours postoperatively and at discharge from the postanesthesia care unit
FEV1 and FVC 24 hours after surgery
Time frame: 24 hours after surgery
Pulmonary shunt 24 hours after surgery
Time frame: 24 hours after surgery
Ventilation-perfusion ratio 24 hours after surgery
Time frame: 24 hours after surgery
Arterial oxygen saturation 24 hours after surgery
Time frame: 24 hours after surgery
Respiratory frequency 24 hours after surgery
Time frame: 24 hours after surgery
Length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Pneumonia
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Respiratory failure after surgery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Atelectasis
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
High temperature
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona R Gätke, M.D. Ph.D. study chair
Department of Anesthesia, Herlev Hospital, University of Copenhagen
Anne K Staehr, M.D. principal investigator
Department of Anesthesia, Herlev Hospital, University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Atelectasis and Respiratory Insufficiency, run by Herlev Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen tension 2 hours after surgery (time frame: 2 hours after end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.