LaparoscopyUDLaSNCT03038061
Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery
A study testing Patients undergoing Laparoscopic Surgery in people with Laparoscopy, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
Position of diaphragm in the region of electrical impedance tomography measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopy
- What is being tested?
- Patients undergoing Laparoscopic Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2015to 24 Feb 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing abdominal laparoscopic surgery
Who cannot join
- morbid obesity
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Detection of Presence of Diaphragm in the Region of Lung Monitoring Using Electrical Impedance Tomography During Laparoscopic Surgery
Position of diaphragm in the region of electrical impedance tomography measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).
Read the detailed description
During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is conducted in order to optimize working space for surgeons. As a side effect, the abdominal pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study will serve during design of a subsequent study dealing with optimization of EIT electrode belt position during laparoscopic surgery.
- Conditions
- Laparoscopy
- Being tested
- Patients undergoing Laparoscopic Surgery
- Keywords
- Diaphragm, EIT, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing Laparoscopic SurgeryOther
Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients undergoing Laparoscopic Surgery Receives: Other: Patients undergoing Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of Diaphragm Detected by Ultrasound
Measurement in midclavicular line
Measured: Within one laparoscopic surgery (1-3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Dec 2015
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
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 LaparoscopyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Prof. Ph.D., Study director, Czech Technical University in PragueMartin Müller, Principal investigator, Czech Technical University in Prague / Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038061
- Sponsor's protocol ID
- NVT108-8/104-2015/ÚVN
- Acronym
- UDLaS
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2017
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
PubMed 20608559Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sorensen MK, VON H Regeur J, Gatke MR. Minimal impairment in pulmonary function following laparoscopic surgery. Acta Anaesthesiol Scand. 2014 Feb;58(2):198-205. doi: 10.1111/aas.12254. Epub 2014 Jan 2.
PubMed 24383568Buzkova K, Muller M, Rara A, Roubik K, Tyll T. Ultrasound detection of diaphragm position in the region for lung monitoring by electrical impedance tomography during laparoscopy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Mar;162(1):43-46. doi: 10.5507/bp.2018.005. Epub 2018 Feb 21.
PubMed 29467544
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Detection of Presence of Diaphragm in the Region of Lung Monitoring Using Electrical Impedance Tomography During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03038061
- Acronym / sponsor ID
- UDLaS / NVT108-8/104-2015/ÚVN
- Conditions
- Laparoscopy
- Keywords
- Diaphragm, EIT, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 31 Jan 2017 (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.
Position of diaphragm in the region of electrical impedance tomography measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).
Detailed description
During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is conducted in order to optimize working space for surgeons. As a side effect, the abdominal pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study will serve during design of a subsequent study dealing with optimization of EIT electrode belt position during laparoscopic surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Patients undergoing Laparoscopic SurgeryPatients undergoing Laparoscopic Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing abdominal laparoscopic surgery
Key exclusion criteria (2 listed)
- morbid obesity
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
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 |
|---|---|---|
| Patients undergoing Laparoscopic SurgeryData are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery). | Other | Experimental group |
Primary outcome
Position of Diaphragm Detected by Ultrasound
Time frame: Within one laparoscopic surgery (1-3 hours)
Measurement in midclavicular line
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 25 Feb 2021.
- Background: PubMed 20608559Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
- Background: PubMed 24383568Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sorensen MK, VON H Regeur J, Gatke MR. Minimal impairment in pulmonary function following laparoscopic surgery. Acta Anaesthesiol Scand. 2014 Feb;58(2):198-205. doi: 10.1111/aas.12254. Epub 2014 Jan 2.
- Derived from this study: PubMed 29467544Buzkova K, Muller M, Rara A, Roubik K, Tyll T. Ultrasound detection of diaphragm position in the region for lung monitoring by electrical impedance tomography during laparoscopy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Mar;162(1):43-46. doi: 10.5507/bp.2018.005. Epub 2018 Feb 21.
- Individual participant dataSharing planned: No
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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.
Karel Roubik, Prof. Ph.D. study director
Czech Technical University in Prague
Martin Müller principal investigator
Czech Technical University in Prague / Military University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients undergoing Laparoscopic Surgery in people with Laparoscopy, run by Czech Technical University in Prague at 1 site in Czechia.
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 1 inclusion and 2 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 25 Feb 2021. 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 Czechia. 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?
Position of Diaphragm Detected by Ultrasound (time frame: Within one laparoscopic surgery (1-3 hours)). 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 NCT03038061, 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 25 Feb 2021.