Major Lower Abdominal SurgeryNCT02040324
Laryngeal Mask Airway in Lower Abdominal Surgery
A study testing Laryngeal mask with gastric access and Endotracheal tube in people with Major Lower Abdominal Surgery, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Major Lower Abdominal Surgery
- What is being tested?
- Laryngeal mask with gastric access and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Mar 2012
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations
About this study
Official title: Comparison of Lung Function in Patients After Lower Abdominal Surgery Exceeding 2hrs Under the Use of Laryngeal Mask vs. Endotracheal Tube for Airway Management
We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.
- Conditions
- Major Lower Abdominal Surgery
- Being tested
- Laryngeal mask with gastric access, Endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask with gastric accessDevice
Endotracheal tubeDevice
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Intubation | Active comparator | Clinical routine for longer lasting procedures Receives: Device: Endotracheal tube |
| Laryngeal Mask | Experimental | Laryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation Receives: Device: Laryngeal mask with gastric access |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function
The lung function is quantified by using Spirometry and pulse oximetry. Spirometry is performed in a standardized way according to the recommendations of the American Thoracic Society (ATS) and European Respiratory Society (ERS)
Measured: one day prior to surgery, 1 hour after surgery (recovery room), at day one after surgery
Secondary outcomes (4)
Vital capacity (VC) measured by spirometry.
Spirometry is performed in a standardized way according to the recommendations of the American Thoracic Society (ATS) and European Respiratory Society (ERS)
Measured: one day prior to surgery, i hour after after surgery (recovery room), at day one after surgery
Forced vital capacity (FVC)
Measured: one day prior to surgery, one hour after surgery (recovery room), at day one after surgery
mid-expiratory flow (MEF 25, 50, 75)
Measured: one day prior to surgery, one hour after surgery, at day one after surgery
Peak expiratory flow (PEF)
Measured: one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Lower Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Daniel Reuter, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Daniel A Reuter, MD, PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040324
- Sponsor's protocol ID
- LMA UKE
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Function in Patients After Lower Abdominal Surgery Exceeding 2hrs Under the Use of Laryngeal Mask vs. Endotracheal Tube for Airway Management
- ClinicalTrials.gov ID
- NCT02040324
- Acronym / sponsor ID
- LMA UKE
- Conditions
- Major Lower Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jan 2014 (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.
We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Intubation | Active comparator | Device: Endotracheal tubeClinical routine for longer lasting procedures |
| Laryngeal Mask | Experimental | Device: Laryngeal mask with gastric accessLaryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal mask with gastric access | Device | Laryngeal Mask |
| Endotracheal tube | Device | Endotracheal Intubation |
Primary outcome
The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function
Time frame: one day prior to surgery, 1 hour after surgery (recovery room), at day one after surgery
The lung function is quantified by using Spirometry and pulse oximetry. Spirometry is performed in a standardized way according to the recommendations of the American Thoracic Society (ATS) and European Respiratory Society (ERS)
4 secondary outcomes
Vital capacity (VC) measured by spirometry.
Time frame: one day prior to surgery, i hour after after surgery (recovery room), at day one after surgery
Forced vital capacity (FVC)
Time frame: one day prior to surgery, one hour after surgery (recovery room), at day one after surgery
mid-expiratory flow (MEF 25, 50, 75)
Time frame: one day prior to surgery, one hour after surgery, at day one after surgery
Peak expiratory flow (PEF)
Time frame: one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery
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 Jan 2014.
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.
Daniel A Reuter, MD, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask with gastric access and Endotracheal tube in people with Major Lower Abdominal Surgery, run by Universitätsklinikum Hamburg-Eppendorf.
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 0 inclusion and 1 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function (time frame: one day prior to surgery, 1 hour after surgery (recovery room), at day one after 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 Jan 2014.