Diaphragmatic DysfunctionDYNASTYNCT06486168
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery
A study testing NIVATS in people with Diaphragmatic Dysfunction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS). Participant will be evaluated during surgery, 2 hours and 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Dysfunction
- What is being tested?
- NIVATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older
- Patient who has read and signed the informed consent form for participation in the study
- Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation
Who cannot join
- Known or detected diaphragmatic dysfunction before the intervention
- Patient not affiliated with the French social security system
- Patient under legal protection, guardianship, or curatorship
- Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)
- Patient in an exclusion period from a previous clinical study
- Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karim GUESSOUS, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Nabil ZANOUN, MD, 01 69 39 15 53 ext. 33, nabil.zanoun@yahoo.fr
Karim GUESSOUS, MD, guess_02@hotmail.fr
About this study
Official title: Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.
The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).
Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.
Read the detailed description
This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.
Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF
- Conditions
- Diaphragmatic Dysfunction
- Being tested
- NIVATS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVATSProcedure or surgery
Non-Intubated Video-Assisted Thoracic Surgery (NIVATS) is the least invasive approach available. It is part of an optimal Enhanced Recovery After Surgery (ERAS) pathway and allows for expanding surgical indications in patients with poor cardio-pulmonary function.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Dysfunction evaluation | Experimental | Not described Receives: Procedure: NIVATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion
The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm.
Measured: Hour 24
Secondary outcomes (6)
Pain evaluation
Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Hour 2
Pain evaluation
Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Hour 24
Diaphragmatic thickening evaluation
Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness
Measured: Hour 2
Diaphragmatic thickening evaluation
Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness
Measured: Hour 24
postoperative complications evaluation
The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.
Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.
Measured: Hour 2
postoperative complications evaluation
The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.
Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start10 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragmatic DysfunctionStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486168
- Sponsor's protocol ID
- 2024-A00912-45
- Acronym
- DYNASTY
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only data strictly relevant to and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be provided.
Publications
Guessous K, Elmaleh Y, Kattou F, Coblence M, Dore P, Zanoun N. Incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery: a prospective, single-centre observational study protocol. BMJ Open. 2025 Dec 31;15(12):e107479. doi: 10.1136/bmjopen-2025-107479.
PubMed 41475807
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.
- ClinicalTrials.gov ID
- NCT06486168
- Acronym / sponsor ID
- DYNASTY / 2024-A00912-45
- Conditions
- Diaphragmatic Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Jul 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.
The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).
Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.
Detailed description
This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.
Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Dysfunction evaluation | Experimental | Procedure: NIVATS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 years or older
- Patient who has read and signed the informed consent form for participation in the study
- Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation
Key exclusion criteria (6 listed)
- Known or detected diaphragmatic dysfunction before the intervention
- Patient not affiliated with the French social security system
- Patient under legal protection, guardianship, or curatorship
- Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)
- Patient in an exclusion period from a previous clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIVATSNon-Intubated Video-Assisted Thoracic Surgery (NIVATS) is the least invasive approach available. It is part of an optimal Enhanced Recovery After Surgery (ERAS) pathway and allows for expanding surgical indications in patients with poor cardio-pulmonary function. | Procedure or surgery | Diaphragmatic Dysfunction evaluation |
Primary outcome
Diaphragmatic excursion
Time frame: Hour 24
The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm.
6 secondary outcomes
Pain evaluation
Time frame: Hour 2
Pain evaluation
Time frame: Hour 24
Diaphragmatic thickening evaluation
Time frame: Hour 2
Diaphragmatic thickening evaluation
Time frame: Hour 24
postoperative complications evaluation
Time frame: Hour 2
postoperative complications evaluation
Time frame: Hour 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 41475807Guessous K, Elmaleh Y, Kattou F, Coblence M, Dore P, Zanoun N. Incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery: a prospective, single-centre observational study protocol. BMJ Open. 2025 Dec 31;15(12):e107479. doi: 10.1136/bmjopen-2025-107479.
- Individual participant dataSharing planned: Yes. Only data strictly relevant to and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be provided.
Related trials for Diaphragmatic Dysfunction
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
Recruiting
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Ventilator Induced Diaphragm Dysfunction
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Recruiting
Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients
Restrictive Lung Diseases
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.
Karim GUESSOUS, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIVATS in people with Diaphragmatic Dysfunction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 6 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil ZANOUN, MD (01 69 39 15 53 ext. 33, nabil.zanoun@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic excursion (time frame: Hour 24). 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 NCT06486168, which also lists 1 linked publication.
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 Jan 2026.