Surgical Anatomy of the Distal Portion of the Phrenic Nerve

NCT04716504 | Completed

• 1 other identifier: APHP201072
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diaphragm Disease

Keywords

Diaphragm pacing; phrenic nerve; -flowing portion

Outcome Measures

Primary Outcomes (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.

  Day 0

Secondary Outcomes (1)

• Inter-Observer Variability

  Up to 3 weeks

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Tenon Hospital, Service : Chirurgie Vasculaire et Thoracique

Paris, 75020, France

Location

Study Officials

• Jalal Assouad, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: January 23, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)