PneumoperitoneumNCT00948571
Influence of Posture and Gas Insufflation on Perioperative Lung Function
An observational study of Pneumoperitoneum, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial summary
Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoperitoneum
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients scheduled for "robotic" prostatectomies 20 patients scheduled for open prostatectomies 20 patients scheduled for open hemicolectomies
Who may be able to join
- Patients older than 18 years of age.
- Patients with normal lung function with respect to age, gender and weight. -Patients scheduled for Prostatectomies, robotic Prostatectomies, and open hemicolectomies.
Who cannot join
- Patients younger than 18 years.
- Patients with pathological lung function.
- Patients with with major cardiac disease.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Prof. Dr. Harald Groeben
Essen, 45136
Harald Groeben, Prof. Dr., ##49201174 ext. 31109, h.groeben@kliniken-essen-mitte.de
Harald Groeben, Prof. Dr.
About this study
Official title: Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.
Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity.
Read the detailed description
Lung function, upper and lower airway resistance measurements are performed in patients in prone horizontal or head tilted down (40°) position. Half of the patients with head down position will have surgery in laparoscopic technique (including gas insufflation to achieve a pneumoperitoneum). Measurements are performed on the day prior to surgery, on the morning of surgery, 30 - 45 minutes, 2 hours, and 24 hours after extubation.
- Conditions
- Pneumoperitoneum
- Keywords
- Vital capacity, FEV1, airway resistance, perioperative changes in lung function
- Medical subject headings
- Pneumoperitoneum
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 |
|---|---|---|
| head down, laparoscopic | 20 patients with laparoscopic surgery (radical robotic prostatectomy) in head down position | |
| head down, open | 20 patients undergoing "open"surgery (open radical prostatectomy) in head down position. | |
| horizontal, open | 20 patients undergoing "open" surgery in horizontal position (open hemicolectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio
Measured: 18 months
Secondary outcomes (1)
Changes in nasal airway resistance
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoperitoneumStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Investigators
- Harald Groeben, Prof. Dr., Principal investigator, Klniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948571
- Sponsor's protocol ID
- 06-3085
- Status last verified
- Jun 2011
- First submitted
- 28 Jul 2009
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
PubMed 7006464Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.
PubMed 19417617Chiu KL, Ryan CM, Shiota S, Ruttanaumpawan P, Arzt M, Haight JS, Chan CT, Floras JS, Bradley TD. Fluid shift by lower body positive pressure increases pharyngeal resistance in healthy subjects. Am J Respir Crit Care Med. 2006 Dec 15;174(12):1378-83. doi: 10.1164/rccm.200607-927OC. Epub 2006 Sep 22.
PubMed 16998093
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.
- ClinicalTrials.gov ID
- NCT00948571
- Acronym / sponsor ID
- 06-3085
- Conditions
- Pneumoperitoneum
- Keywords
- Vital capacity, FEV1, airway resistance, perioperative changes in lung function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 29 Jul 2009 (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.
Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity.
Detailed description
Lung function, upper and lower airway resistance measurements are performed in patients in prone horizontal or head tilted down (40°) position. Half of the patients with head down position will have surgery in laparoscopic technique (including gas insufflation to achieve a pneumoperitoneum). Measurements are performed on the day prior to surgery, on the morning of surgery, 30 - 45 minutes, 2 hours, and 24 hours after extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| head down, laparoscopic | – | –20 patients with laparoscopic surgery (radical robotic prostatectomy) in head down position |
| head down, open | – | –20 patients undergoing "open"surgery (open radical prostatectomy) in head down position. |
| horizontal, open | – | –20 patients undergoing "open" surgery in horizontal position (open hemicolectomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients scheduled for "robotic" prostatectomies 20 patients scheduled for open prostatectomies 20 patients scheduled for open hemicolectomies
Key inclusion criteria (2 listed)
- Patients older than 18 years of age.
- Patients with normal lung function with respect to age, gender and weight. -Patients scheduled for Prostatectomies, robotic Prostatectomies, and open hemicolectomies.
Key exclusion criteria (3 listed)
- Patients younger than 18 years.
- Patients with pathological lung function.
- Patients with with major cardiac disease.
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
Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio
Time frame: 18 months
1 secondary outcome
Changes in nasal airway resistance
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Background: PubMed 7006464Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
- Background: PubMed 19417617Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.
- Background: PubMed 16998093Chiu KL, Ryan CM, Shiota S, Ruttanaumpawan P, Arzt M, Haight JS, Chan CT, Floras JS, Bradley TD. Fluid shift by lower body positive pressure increases pharyngeal resistance in healthy subjects. Am J Respir Crit Care Med. 2006 Dec 15;174(12):1378-83. doi: 10.1164/rccm.200607-927OC. Epub 2006 Sep 22.
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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.
Harald Groeben, Prof. Dr. principal investigator
Klniken Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum, run by Kliniken Essen-Mitte at 1 site in Germany.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harald Groeben, Prof. Dr. (##49201174 ext. 31109, h.groeben@kliniken-essen-mitte.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948571, which also lists 3 linked publications.
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 28 Jun 2011.