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Diaphragm DiseaseDANPNCT04716504

Surgical Anatomy of the Distal Portion of the Phrenic Nerve

An observational study of Diaphragm Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prolonged mechanical ventilation has been shown to induce diaphragm dysfunction. Temporary diaphragm pacing is an interesting lead to halt or slow diaphragm dysfunction. A detailed description of the distal portion of the phrenic nerve would be the start for developing a new surgical approach for diaphragm pacing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diaphragm Disease
How many people
54 participants
Where
1 siteFrance
Study dates
23 Jan 2021to 30 Apr 2021
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
  • Adult, Older adult

Study population: The study population will be patients who consult for a benign or malignant pulmonary lesion. Resection of the lesion would have to be done by a minimally invasive approach (video-assisted thoracoscopic surgery or robotic-assisted thoracoscopic surgery).

Who may be able to join

  • patients older than 18 years-old and not under a protection measure
  • patients undergoing lung resection for a malignant or benign lesion
  • surgical approach by minimally invasive technique (video-assisted thoracoscopic surgery or robotic-assisted thoracoscopic surgery)

Who cannot join

  • surgical approach by thoracotomy
  • intense pleural adhesions between the lung parenchyma and the mediastinal pleura.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Tenon Hospital, Service : Chirurgie Vasculaire et Thoracique

    Paris, 75020

Other trials in France

About this study

Prolonged mechanical ventilation has been shown to induce diaphragm dysfunction. Temporary diaphragm pacing is an interesting lead to halt or slow diaphragm dysfunction. A detailed description of the distal portion of the phrenic nerve would be the start for developing a new surgical approach for diaphragm pacing. Its in that perspective that we are launching a clinical observational study of the distal portion of the phrenic nerve in patients who undergo minimally invasive thoracic surgey. We hypothetize that the density of the fatty tissue surrounding the distal portion of the phrenic nerve might influence efficiency of the electrode during diaphragm pacing. The objective of this study is to find a correlation between the amount of fatty tissue around the nerve and the body mass index of individuals.

Read the detailed description

Implanted phrenic nerve stimulation is a validated technique to produce lung ventilation when the neural drive to breathe is abolished (e.g. congenital central alveolar ventilation during sleep, or during wakefulness in severe forms of the disease) or defective (e.g. periodic breathing due to chronic heart failure), or when it cannot reach the phrenic spinal motoneurons (e.g. high cervical spinal cord lesions). Several implantation techniques have been described. They include the surgical implantation of contact electrodes in intimate exposure with the trunk of the nerve, the laparoscopic implantation of hook electrodes within the diaphragm in the vicinity of the phrenic nerve endings (ref), and transvenous approaches that can be permanent (pacemaker like device) or temporary (central venous catheter-borne electrodes). The surgical implantation of electrodes in contact with the phrenic nerve ("periphrenic electrodes") is the better established of these techniques, having been described in the 1970s and continuously used since. Periphrenic electrodes have been implanted at the bottom of the cervical path of the nerve. This cervical approach is quick and easy to implement, but the results can be compromised by system damages resulting from neck movements and by the fact that the phrenic nerve is often anatomically incomplete at this level (namely above the junction with the accessory phrenic nerve). For these reasons, periphrenic electrodes are typically implanted within the thorax, at the level of the vena cava on the right and of the pulmonary hilum on the left. These locations are readily accessible by use of video-assisted thoracoscopic surgery or thoracotomy. Careful dissection of the phrenic nerve is necessary to separate it from the underlying anatomical plane and create the necessary access to position the electrodes. The possibility to position periphrenic electrodes over a segment of the phrenic nerve where it would be fully constituted and to do so without the need for nerve dissection would render intrathoracic phrenic nerve stimulation easier and safer to implement. It would also open the possibility of temporary implantation. From the anatomical description of the terminal branching of the phrenic nerve toward different portions of the diaphragm , we hypothesized that such "free" segment would exist between the point where the phrenic nerve pathway leaves the anterolateral angle of the pericardial base in direction of the diaphragm and the point where the phrenic nerve branches before entering the diaphragm muscle mass. This study was therefore designed to determine whether or not a free phrenic segment exists between the cardiophrenic angle and the diaphragm, to describe the anatomical characteristics of this segment, and to compare the nature, number and size of its constituting fibers with the corresponding characteristics as identified at the usual site of implantation of intrathoracic periphrenic electrodes. To this aim, we first performed a human cadaver study. This study allowed us to describe a fatty tissue surrounding the phrenic nerve which density vary from one patient to another, and from one side to the other. During routine surgical interventions by minimally invasive approach, we want to complete our observation by searching for a correlation between patients body mass index (BMI) and the density of fatty tissue surrounding the phrenic nerve.

The patients, depending on their BMI will be divided in three categories: - Category 1: 18,5 kg/m2 < BMI < 24,9 kg/m2 / - Category 2: 25 kg/m2 < BMI < 29,9 kg/m2 / - Category 3: 30,0 kg/m2 < BMI < 34,9 kg/m2 Fifteen patients will be included in each category. A fifteen seconds recording of each phrenic nerve during minimally invasive surgery will be reviewed by 2 independent observers in order to classify the phrenic nerve in three categories: - type 1: pericadiophrenic bundle is free of any relevant surrounding fatty tissue / - Type 2: pericardiophre-nic bundle is surrounded by one fringe of fatty tissue / - Type 3: pericardiophrenic bundle is surrounded by multiple fringes of fatty tissue

Keywords
Diaphragm pacing, phrenic nerve, -flowing portion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04716504
Study groupRoleWhat they receive
Minimally invasive surgery for a benign or malignant pulmonary lesion.The patients will be divided in three categories depending on the Body Mass Index: * Category 1: 18,5 kg/m2 < BMI < 24,9 kg/m2 -Category 2: 25 kg/m2 < BMI < 29,9 kg/m2 / * Category 3: 30,0 kg/m2 < BMI < 34,9 kg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. correlation between body mass index and fatty tissue surrounding phrenic nerve

    During the initial phase of the surgical intervention, the surgeons would explore the thoracic cavity for potential contra-indications of any lung resection. While doing so, they would identify the phrenic nerve in order to prevent any lesions. During that particular moment, the recording option on the camera would be activated to register exploration of the distal portion of the phrenic nerve before it ends in the diaphragm. Two independent observers would review this video and classify the phrenic nerve depending on the amount of fatty tissue surrounding it.

    Measured: Day 0

Secondary outcomes (1)
  1. Inter-Observer Variability

    after classification of fatty tissue around the phrenic nerve by the two observers, inter observer variability will be assessed by using Kappa coefficient from Cohen.

    Measured: Up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start23 Jan 2021
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Resources

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716504
Sponsor's protocol ID
APHP201072
Acronym
DANP
Status last verified
Oct 2021
First submitted
15 Jan 2021
Last updated
25 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diaphragm Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 3 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 Oct 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 France. 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?

correlation between body mass index and fatty tissue surrounding phrenic nerve (time frame: Day 0). 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 Oct 2021.

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