Diaphragm Paralysis: Surgery or Mechanical Ventialion

NCT05027035 | Recruiting

• 1 other identifier: 80-87700-98-22188
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Summary Rationale: The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. In patients with diaphragm paralysis the treatment (surgery versus non-invasive ventilation) is based on physician preference, not sound scientific evidence. Clearly studies are needed to guide a scientific decision making. Objective: In this pilot study the we want to know the clinical relevant effect of both therapies on EQ-5D\_5L, the latter being the primary outcome. Finally, it will show the investigators the costs of both therapies form a societal perspective. Study design: open-label, multi center intervention pilot study Study population: 20 participants \>18 year and diagnosed with a unilateral diaphragm paralysis resulting from phrenic nerve injury. Intervention: 10 participants for surgical plication and 10 participants for nocturnal non-invasive ventilation while on the wating list for surgical plication. Main study parameters/endpoints: The goal of the pilot study is to describe the effect of both plication and NIV on the endpoints of the intended efficiency study. The intended primary endpoint is quality of life as measured by the EQ-5D-5L questionnaire. Secondary endpoints are; the Medical Research Council (MRC) dyspnoea scale, the Diaphragmatic Paralysis Questionnaire, Borg dyspnoea score, 6 minute walk test, spirometry in both sitting and supine position, a polysomnography and transcutaneous measurement of carbon dioxide an oxygen saturation at night.

Conditions

Diaphragm Paralysis

Keywords

mechanical ventilation; surgical plication of the diaphragm

Outcome Measures

Primary Outcomes (2)

• Comparing surgical plication versus non-invasive ventilation .

  10 patients surgical plication and 10 patients non-invasive ventilation while on the waiting list

  0-15 months

• Change in EuorQOL 5 Dimensions 5 Level (EQ-5D-5L questionnaire) range 1-1-1-1-1 (best score) to 5-5-5-5-5 (worst score)

  questionnaire to score QUALY

  baseline and 3 and 6 months

Study Arms (2)

Surgical plication

ACTIVE COMPARATOR

Surgical plication of the diaphragm

Other: surgical plication" or "nocturnal non-invasive ventilation

Mechanical ventilation

ACTIVE COMPARATOR

Non-invasive ventiatilatory support while on the waiting list for surgical plication

Other: surgical plication" or "nocturnal non-invasive ventilation

Interventions

surgical plication" or "nocturnal non-invasive ventilation OTHER

10 participants for surgical plication and 10 participants for nocturnal non-invasive ventilation.

Mechanical ventilation; Surgical plication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• diagnosed with a unilateral diaphragm paralysis based on isolated phrenic nerve injury.
• Unilateral diaphragm paralysis is defined as follows: complaints of dyspnea and / or orthopnea combined with a drop in VC of more than 15% when change from upright to supine position and a positive sniff test during fluoroscopy or ultrasonography. A positive sniff test means that the diaphragm stands still or even moves in cranial direction (paradoxical movement ) during the sniff inspiratory maneuver.
• Ability to provide written consent
• Time between diagnosis and treatment should be at least 1 year

You may not qualify if:

• Patients diagnosed with a bilateral diaphragm paralysis.
• A diaphragm paralysis in combination with a more systemic neurological or neuromuscular disorder like for example Amyotrophic Lateral Sclerosis ,
• Hypercapnia during daytime (PaCO2 \> 6.0 kPa)
• Radiotherapy of the thorax
• Contra indication for diaphragm surgery.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Wijkstra, prof

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Wijkstra, prof

CONTACT

+31 50 3613200; p.j.wijkstra@umcg.nl

Anda Hazenberg, dr.

CONTACT

+31 50 3613200; a.hazenberg@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P.J. Wijkstra

Model Details: open-label, multi center, intervention pilot study

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 30, 2021
• Study Start: June 28, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)