CholecystolithiasisHFJVNCT01289379
The Effect of High Frequency Jet Ventilation (HFJV)During Laparoscopic Operations
A study testing High Frequency Jet Ventilation and HFJV in people with Cholecystolithiasis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- High Frequency Jet Ventilation and HFJV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients, undergoing laparoscopic surgery for Symptomatic cholecystolithiasis.
Who cannot join
- ASA 3 and 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Frequency Jet Ventilation (HFJV)on Pneumoperitoneum Induced Cardiovascular Changes, During Laparoscopic Surgery.
Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery.
- Conditions
- Cholecystolithiasis
- Being tested
- High Frequency Jet Ventilation, HFJV
- Keywords
- pneumoperitoneum, laparoscopy, HFJV, cardiovascular, Symptomatic
- Medical subject headings
- Cholecystolithiasis, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Jet VentilationProcedure or surgery
HFJVProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HFJV | Experimental | Not described Receives: Procedure: High Frequency Jet Ventilation; Procedure: HFJV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac functionality (Cardiac output,VOLUME)
Cardiac functionality (Cardiac output,VOLUME)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystolithiasisStudies 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
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289379
- Sponsor's protocol ID
- Bickel-HFJV
- Acronym
- HFJV
- Status last verified
- Feb 2011
- First submitted
- 19 Oct 2010
- Last updated
- 3 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Frequency Jet Ventilation (HFJV)on Pneumoperitoneum Induced Cardiovascular Changes, During Laparoscopic Surgery.
- ClinicalTrials.gov ID
- NCT01289379
- Acronym / sponsor ID
- HFJV / Bickel-HFJV
- Conditions
- Cholecystolithiasis
- Keywords
- pneumoperitoneum, laparoscopy, HFJV, cardiovascular, Symptomatic
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- First posted
- 3 Feb 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.
Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFJV | Experimental | Procedure: High Frequency Jet Ventilation, Procedure: HFJV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patients, undergoing laparoscopic surgery for Symptomatic cholecystolithiasis.
Key exclusion criteria (1 listed)
- ASA 3 and 4
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 |
|---|---|---|
| High Frequency Jet Ventilation | Procedure or surgery | HFJV |
| HFJV | Procedure or surgery | HFJV |
Primary outcome
Cardiac functionality (Cardiac output,VOLUME)
Cardiac functionality (Cardiac output,VOLUME)
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 3 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Jet Ventilation and HFJV in people with Cholecystolithiasis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 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 3 Feb 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 Israel. 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?
Cardiac functionality (Cardiac output,VOLUME). 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 3 Feb 2011.