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Heart Rate Variability in Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537417
Recruitment Status : Unknown
Verified May 2018 by Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus

Study Description
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Brief Summary:
Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy

Condition or disease Intervention/treatment
Pneumothorax Procedure: for thoracoscopic ablation of cervical sympathetic chain

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Heart Rate Variability in Ventilated Patients Undergoing Tension Pneumothorax for Thoracoscopic Cervical Sympathectomy
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Groups and Cohorts
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Group/Cohort Intervention/treatment
Tension pneumothorax group
Patients undergoing intentional pneumothorax for thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis
 Procedure: for thoracoscopic ablation of cervical sympathetic chain
bilateral thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy for hyperhidrosis
Criteria

Inclusion Criteria:

  • age 15 - 50 years
  • body mass index 25 - 45

Exclusion Criteria:

  • heart rate other than sinus
  • cardiac pacemaker status
  • heart transplant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537417


Contacts
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Contact: Amit Lehavi, MD 972-50-20161419 amit.lehavi@gmail.com
Contact: Amit Lehavi, MD 972-50-2061419 amit.lehavi@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus
More Information
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Responsible Party: Dr. Amit Lehavi MD FANZCA, Director of Pediatric Anesthesia, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03537417    
Other Study ID Numbers: RMB 144-18
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases