Diaphragm IssuesNCT06257589
A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis
An observational study of Diaphragm Issues and Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure, run by Advanced Reconstructive Surgery Alliance at 2 sites in United States.
Trial summary
A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diaphragm Issues, Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure, Breath Shortness
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2023to 10 Oct 2026
- 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 to 95 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.
Who may be able to join
- Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.
Who cannot join
- Age 18 and below.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Reconstructive Surgery Alliance
Red Bank, New Jersey, 07701
Institute for Advanced Reconstruction
Shrewsbury, New Jersey, 07702
About this study
Official title: A Grounded Theory of Phrenic Nerve Reconstruction for the Treatment of Diaphragm Paralysis - A Biopsychosocial Approach to Surgical Evaluation and Outcomes
A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.
- Conditions
- Diaphragm Issues, Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure, Breath Shortness, Diaphragmatic Paralysis
- Keywords
- Grounded Theory, Mixed Methods, Chart Review, Diaphragmatic Paralysis
- Medical subject headings
- Paralysis, Dyspnea, Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intrathoracic Approach | Patients who have undergone the intrathoracic approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis. NO INTERVENTION. | |
| Cervical Approach | Patients who have undergone the cervical approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis. NO INTERVENTION. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Position of Diaphragm.
Radiographic Thoracic Imaging.
Measured: Up to 12 Months.
Pulmonary Function.
Pulmonary Function Test (PFT).
Measured: Up to 12 Months.
Secondary outcomes (2)
Health-Related Quality of Life (HRQoL).
SF-36 / RAND Survey.
Measured: Up to 12 Months.
Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.
AEs related to the procedure reported in the medical chart.
Measured: Up to 24 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start10 Oct 2023
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diaphragm IssuesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Reconstructive Surgery Alliance
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Matthew Kaufman, MD, Advanced Reconstructive Surgery Alliance
- Investigators
- Matthew Kaufman, MD, Principal investigator, Advanced Reconstructive Surgery Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257589
- Sponsor's protocol ID
- GT-Phase-1
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Individual participant data (IPD) will not be shared.
Publications
Kaufman MR, Ferro N, Paulin E. Phrenic nerve paralysis and phrenic nerve reconstruction surgery. Handb Clin Neurol. 2022;189:271-292. doi: 10.1016/B978-0-323-91532-8.00003-3.
PubMed 36031309Kaufman MR, Chang EI, Bauer T, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Phrenic Nerve Reconstruction for Effective Surgical Treatment of Diaphragmatic Paralysis. Ann Plast Surg. 2021 Sep 1;87(3):310-315. doi: 10.1097/SAP.0000000000002896.
PubMed 34397519Kaufman MR, Bauer T, Onders RP, Brown DP, Chang EI, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Treatment for bilateral diaphragmatic dysfunction using phrenic nerve reconstruction and diaphragm pacemakers. Interact Cardiovasc Thorac Surg. 2021 May 10;32(5):753-760. doi: 10.1093/icvts/ivaa324.
PubMed 33432336Kaufman MR, Bauer T, Campbell S, Rossi K, Elkwood A, Jarrahy R. Prospective analysis of a surgical algorithm to achieve ventilator weaning in cervical tetraplegia. J Spinal Cord Med. 2022 Jul;45(4):531-535. doi: 10.1080/10790268.2020.1829417. Epub 2020 Oct 15.
PubMed 33054689Kaufman MR, Willekes LJ, Elkwood AI, Rose MI, Patel TR, Ashinoff RL, Colicchio AR. Diaphragm paralysis caused by transverse cervical artery compression of the phrenic nerve: the Red Cross syndrome. Clin Neurol Neurosurg. 2012 Jun;114(5):502-5. doi: 10.1016/j.clineuro.2012.01.048. Epub 2012 Feb 24.
PubMed 22366245Kaufman MR, Elkwood AI, Brown D, Cece J, Martins C, Bauer T, Weissler J, Rezzadeh K, Jarrahy R. Long-Term Follow-Up after Phrenic Nerve Reconstruction for Diaphragmatic Paralysis: A Review of 180 Patients. J Reconstr Microsurg. 2017 Jan;33(1):63-69. doi: 10.1055/s-0036-1588018. Epub 2016 Sep 25.
PubMed 27665114Kaufman MR, Elkwood AI, Colicchio AR, CeCe J, Jarrahy R, Willekes LJ, Rose MI, Brown D. Functional restoration of diaphragmatic paralysis: an evaluation of phrenic nerve reconstruction. Ann Thorac Surg. 2014 Jan;97(1):260-6. doi: 10.1016/j.athoracsur.2013.09.052. Epub 2013 Nov 19.
PubMed 24266954Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Saad A, Caccavale R, Bocage JP, Cole J, Soriano A, Fein E. Reinnervation of the paralyzed diaphragm: application of nerve surgery techniques following unilateral phrenic nerve injury. Chest. 2011 Jul;140(1):191-197. doi: 10.1378/chest.10-2765. Epub 2011 Feb 24.
PubMed 21349932Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Fields R, Brown D. Surgical treatment of permanent diaphragm paralysis after interscalene nerve block for shoulder surgery. Anesthesiology. 2013 Aug;119(2):484-7. doi: 10.1097/ALN.0b013e31829c2f22. No abstract available.
PubMed 23838708Kaufman MR, Elkwood AI, Aboharb F, Cece J, Brown D, Rezzadeh K, Jarrahy R. Diaphragmatic reinnervation in ventilator-dependent patients with cervical spinal cord injury and concomitant phrenic nerve lesions using simultaneous nerve transfers and implantable neurostimulators. J Reconstr Microsurg. 2015 Jun;31(5):391-5. doi: 10.1055/s-0035-1549159. Epub 2015 Apr 13.
PubMed 25868155
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Grounded Theory of Phrenic Nerve Reconstruction for the Treatment of Diaphragm Paralysis - A Biopsychosocial Approach to Surgical Evaluation and Outcomes
- ClinicalTrials.gov ID
- NCT06257589
- Acronym / sponsor ID
- GT-Phase-1
- Conditions
- Diaphragm Issues, Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure, Breath Shortness, Diaphragmatic Paralysis
- Keywords
- Grounded Theory, Mixed Methods, Chart Review, Diaphragmatic Paralysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Advanced Reconstructive Surgery AllianceOther government
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 14 Feb 2024 (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.
A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathoracic Approach | – | –Patients who have undergone the intrathoracic approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis. NO INTERVENTION. |
| Cervical Approach | – | –Patients who have undergone the cervical approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis. NO INTERVENTION. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.
Key inclusion criteria (1 listed)
- Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.
Key exclusion criteria (1 listed)
- Age 18 and below.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic Position of Diaphragm.
Time frame: Up to 12 Months.
Radiographic Thoracic Imaging.
Pulmonary Function.
Time frame: Up to 12 Months.
Pulmonary Function Test (PFT).
2 secondary outcomes
Health-Related Quality of Life (HRQoL).
Time frame: Up to 12 Months.
Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.
Time frame: Up to 24 Months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 36031309Kaufman MR, Ferro N, Paulin E. Phrenic nerve paralysis and phrenic nerve reconstruction surgery. Handb Clin Neurol. 2022;189:271-292. doi: 10.1016/B978-0-323-91532-8.00003-3.
- Background: PubMed 34397519Kaufman MR, Chang EI, Bauer T, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Phrenic Nerve Reconstruction for Effective Surgical Treatment of Diaphragmatic Paralysis. Ann Plast Surg. 2021 Sep 1;87(3):310-315. doi: 10.1097/SAP.0000000000002896.
- Background: PubMed 33432336Kaufman MR, Bauer T, Onders RP, Brown DP, Chang EI, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Treatment for bilateral diaphragmatic dysfunction using phrenic nerve reconstruction and diaphragm pacemakers. Interact Cardiovasc Thorac Surg. 2021 May 10;32(5):753-760. doi: 10.1093/icvts/ivaa324.
- Background: PubMed 33054689Kaufman MR, Bauer T, Campbell S, Rossi K, Elkwood A, Jarrahy R. Prospective analysis of a surgical algorithm to achieve ventilator weaning in cervical tetraplegia. J Spinal Cord Med. 2022 Jul;45(4):531-535. doi: 10.1080/10790268.2020.1829417. Epub 2020 Oct 15.
- Background: PubMed 22366245Kaufman MR, Willekes LJ, Elkwood AI, Rose MI, Patel TR, Ashinoff RL, Colicchio AR. Diaphragm paralysis caused by transverse cervical artery compression of the phrenic nerve: the Red Cross syndrome. Clin Neurol Neurosurg. 2012 Jun;114(5):502-5. doi: 10.1016/j.clineuro.2012.01.048. Epub 2012 Feb 24.
- Background: PubMed 27665114Kaufman MR, Elkwood AI, Brown D, Cece J, Martins C, Bauer T, Weissler J, Rezzadeh K, Jarrahy R. Long-Term Follow-Up after Phrenic Nerve Reconstruction for Diaphragmatic Paralysis: A Review of 180 Patients. J Reconstr Microsurg. 2017 Jan;33(1):63-69. doi: 10.1055/s-0036-1588018. Epub 2016 Sep 25.
- Background: PubMed 24266954Kaufman MR, Elkwood AI, Colicchio AR, CeCe J, Jarrahy R, Willekes LJ, Rose MI, Brown D. Functional restoration of diaphragmatic paralysis: an evaluation of phrenic nerve reconstruction. Ann Thorac Surg. 2014 Jan;97(1):260-6. doi: 10.1016/j.athoracsur.2013.09.052. Epub 2013 Nov 19.
- Background: PubMed 21349932Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Saad A, Caccavale R, Bocage JP, Cole J, Soriano A, Fein E. Reinnervation of the paralyzed diaphragm: application of nerve surgery techniques following unilateral phrenic nerve injury. Chest. 2011 Jul;140(1):191-197. doi: 10.1378/chest.10-2765. Epub 2011 Feb 24.
- Background: PubMed 23838708Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Fields R, Brown D. Surgical treatment of permanent diaphragm paralysis after interscalene nerve block for shoulder surgery. Anesthesiology. 2013 Aug;119(2):484-7. doi: 10.1097/ALN.0b013e31829c2f22. No abstract available.
- Background: PubMed 25868155Kaufman MR, Elkwood AI, Aboharb F, Cece J, Brown D, Rezzadeh K, Jarrahy R. Diaphragmatic reinnervation in ventilator-dependent patients with cervical spinal cord injury and concomitant phrenic nerve lesions using simultaneous nerve transfers and implantable neurostimulators. J Reconstr Microsurg. 2015 Jun;31(5):391-5. doi: 10.1055/s-0035-1549159. Epub 2015 Apr 13.
- Individual participant dataSharing planned: No. No Individual participant data (IPD) will not be shared.
Related trials for Diaphragm Issues
RecruitingObservational study
Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
Diaphragm Issues, Mechanical Ventilation Complication
Not yet recruitingObservational study
Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis
Diaphragm Issues
Not yet recruiting
Comparison of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery in Diaphragmatic Function
Diaphragm Issues
Recruiting
STIMIT Activator 1 IDE Study
Diaphragm Issues
Not yet recruitingObservational study
The Effect of BIPAP on Diaphragmatic Function
BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues
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.
Matthew Kaufman, MD principal investigator
Advanced Reconstructive Surgery Alliance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Issues and Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure, run by Advanced Reconstructive Surgery Alliance at 2 sites in United States.
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 1 inclusion and 1 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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?
Radiographic Position of Diaphragm. (time frame: Up to 12 Months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257589, which also lists 10 linked publications.
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 14 Feb 2024.