PneumothoraxNCT03537417
Heart Rate Variability in Pneumothorax
An observational study of Pneumothorax, run by Rambam Health Care Campus.
Trial summary
Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- for thoracoscopic ablation of cervical sympathetic chain
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Jun 2019
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy for hyperhidrosis
Who may be able to join
- age 15 - 50 years
- body mass index 25 - 45
Who cannot join
- heart rate other than sinus
- cardiac pacemaker status
- heart transplant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in Heart Rate Variability in Ventilated Patients Undergoing Tension Pneumothorax for Thoracoscopic Cervical Sympathectomy
Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy
- Conditions
- Pneumothorax
- Being tested
- for thoracoscopic ablation of cervical sympathetic chain
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
for thoracoscopic ablation of cervical sympathetic chainProcedure or surgery
bilateral thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis
| Study group | Role | What they receive |
|---|---|---|
| Tension pneumothorax group | Patients undergoing intentional pneumothorax for thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis Receives: Procedure: for thoracoscopic ablation of cervical sympathetic chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate variability
Non linear changes in R-R intervals extracted from ECG
Measured: From immediately after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumothorax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537417
- Sponsor's protocol ID
- RMB 144-18
- Status last verified
- May 2018
- First submitted
- 15 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Heart Rate Variability in Ventilated Patients Undergoing Tension Pneumothorax for Thoracoscopic Cervical Sympathectomy
- ClinicalTrials.gov ID
- NCT03537417
- Acronym / sponsor ID
- RMB 144-18
- Conditions
- Pneumothorax
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 25 May 2018 (actual)
- 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.
Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tension pneumothorax group | – | Procedure: for thoracoscopic ablation of cervical sympathetic chainPatients undergoing intentional pneumothorax for thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy for hyperhidrosis
Key inclusion criteria (2 listed)
- age 15 - 50 years
- body mass index 25 - 45
Key exclusion criteria (3 listed)
- heart rate other than sinus
- cardiac pacemaker status
- heart transplant
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 |
|---|---|---|
| for thoracoscopic ablation of cervical sympathetic chainbilateral thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis | Procedure or surgery | Tension pneumothorax group |
Primary outcome
Changes in heart rate variability
Time frame: From immediately after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumothorax
Non linear changes in R-R intervals extracted from ECG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by Rambam Health Care Campus.
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 25 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Lehavi, MD (972-50-20161419, amit.lehavi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate variability (time frame: From immediately after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumothorax). 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 25 May 2018.