Surgery, CardiacINDYDNCT04276844
Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery
An observational study of Surgery, Cardiac, run by CMC Ambroise Paré at 1 site in France.
Trial summary
Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac
- What is being tested?
- Ultrasonography using the two-dimensional (2D) mode and Respiratory Functional Explorations
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2020to 20 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients undergoing cardiac surgery
Who may be able to join
- Patients undergoing cardiac surgery requiring sternotomy
- Consent for participation
- Affiliation to the social security system
Who cannot join
- Contraindication to preoperative respiratory functional explorations
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.
Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing < 9 mm for woman and < 10 mm for man, 2) an excursion after sniff test < 16 mm for woman and < 18 mm for man and 3) an excursion during deep breathing < 37 mm for woman and < 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.
Read more
DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.
The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.
Read the detailed description
Diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.
- Conditions
- Surgery, Cardiac
- Being tested
- Ultrasonography using the two-dimensional (2D) mode, Respiratory Functional Explorations
- Keywords
- Diaphragmatic paralysis, Respiratory complications
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography using the two-dimensional (2D) modeDiagnostic test
Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Respiratory Functional ExplorationsDiagnostic test
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7
| Study group | Role | What they receive |
|---|---|---|
| Non diaphragmatic dysfunction at day 7 post-surgery | Diaphragmatic displacement after sniff test ≥ 16 mm for women and ≥ 18 mm for men Receives: Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode | |
| Persistent diaphragmatic dysfunction at day 7 post-surgery | Diaphragmatic displacement after sniff test < 16 mm for women and < 18 mm for men Receives: Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode; Diagnostic Test: Respiratory Functional Explorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery
Diaphragmatic excursion measured during sniff test (displacement, mm)
Measured: 8 days
Secondary outcomes (4)
Incidence of respiratory complications
Occurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (>24h) or prolonged non-invasive ventilation (>48h)
Measured: up to 2 months
Intensive Care Unit (ICU) length of stay
Duration of ICU stay measured in days
Measured: up to 2 months
Hospital length of stay
Duration of hospitalization measured in days
Measured: up to 2 months
Respiratory function test in the group with persistent diaphragmatic dysfunction
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7 and compared to day 0
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start4 Mar 2020
- Primary completion3 Nov 2020
- Study completion20 Jan 2021
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 Surgery, CardiacStudies 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
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276844
- Sponsor's protocol ID
- 2019/06
- Acronym
- INDYD
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laghlam D, Naudin C, Srour A, Monsonego R, Malvy J, Rahoual G, Squara P, Nguyen LS, Estagnasie P. Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study. Can J Anaesth. 2023 Feb;70(2):228-236. doi: 10.1007/s12630-022-02360-8. Epub 2022 Dec 13.
PubMed 36513852
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04276844
- Acronym / sponsor ID
- INDYD / 2019/06
- Conditions
- Surgery, Cardiac
- Keywords
- Diaphragmatic paralysis, Respiratory complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 19 Feb 2020 (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.
Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.
Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing < 9 mm for woman and < 10 mm for man, 2) an excursion after sniff test < 16 mm for woman and < 18 mm for man and 3) an excursion during deep breathing < 37 mm for woman and < 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.
DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.
The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.
Detailed description
Diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non diaphragmatic dysfunction at day 7 post-surgery | – | Diagnostic Test: Ultrasonography using the two-dimensional (2D) modeDiaphragmatic displacement after sniff test ≥ 16 mm for women and ≥ 18 mm for men |
| Persistent diaphragmatic dysfunction at day 7 post-surgery | – | Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode, Diagnostic Test: Respiratory Functional ExplorationsDiaphragmatic displacement after sniff test < 16 mm for women and < 18 mm for men |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients undergoing cardiac surgery
Key inclusion criteria (3 listed)
- Patients undergoing cardiac surgery requiring sternotomy
- Consent for participation
- Affiliation to the social security system
Key exclusion criteria (4 listed)
- Contraindication to preoperative respiratory functional explorations
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
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 |
|---|---|---|
| Ultrasonography using the two-dimensional (2D) modeDiaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients. | Diagnostic test | Non diaphragmatic dysfunction at day 7 post-surgery, Persistent diaphragmatic dysfunction at day 7 post-surgery |
| Respiratory Functional ExplorationsForced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7 | Diagnostic test | Persistent diaphragmatic dysfunction at day 7 post-surgery |
Primary outcome
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery
Time frame: 8 days
Diaphragmatic excursion measured during sniff test (displacement, mm)
4 secondary outcomes
Incidence of respiratory complications
Time frame: up to 2 months
Intensive Care Unit (ICU) length of stay
Time frame: up to 2 months
Hospital length of stay
Time frame: up to 2 months
Respiratory function test in the group with persistent diaphragmatic dysfunction
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 36513852Laghlam D, Naudin C, Srour A, Monsonego R, Malvy J, Rahoual G, Squara P, Nguyen LS, Estagnasie P. Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study. Can J Anaesth. 2023 Feb;70(2):228-236. doi: 10.1007/s12630-022-02360-8. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Cardiac, run by CMC Ambroise Paré 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 4 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 8 Apr 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?
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?
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery (time frame: 8 days). 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 NCT04276844, 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 8 Apr 2026.