Diaphragm InjuryNCT05532033
High Flow Nasal Cannula and Diaphragmatic Function
A study testing High flow nasal cannula and Facial mask in people with Diaphragm Injury and Postoperative Complications, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diaphragm Injury, Postoperative Complications
- What is being tested?
- High flow nasal cannula and Facial mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- 9 Aug 2022to 22 Oct 2023
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective thoracic surgery
Who cannot join
- ASA score >3
- Body mass index > 35 kg/m2
- History of neuromuscular disease
- History of thoracic surgery
- Phrenic nerve paisy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery
Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask
- Conditions
- Diaphragm Injury, Postoperative Complications
- Being tested
- High flow nasal cannula, Facial mask
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
A device able to delivery high flow oxygen therapy
Facial maskDevice
standard oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula | Experimental | Two hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours Receives: Device: High flow nasal cannula |
| Standard oxygen therapy | Active comparator | Two hours after extubation patients will received standard oxygenation therapy for 24 hours Receives: Device: Facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diaphragmatic dysfunction
Ultrasound evaluation of diaphragmatic dysfunction
Measured: 24 hours after surgery
Secondary outcomes (1)
Postoperative pulmonary complication
Incidence of postoperative pulmonary complication
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start9 Aug 2022
- Primary completion15 Oct 2023
- Study completion22 Oct 2023
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 Diaphragm InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532033
- Sponsor's protocol ID
- HFNCThoracic
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study dataset will be shared in anonymous form under reasonable request
Publications
Fogagnolo A, Grasso S, Dres M, Azzolina D, Dalla Corte F, Dolci G, Tamburini N, De Paoli G, Murgolo F, Pedarzani E, Andalo A, Volta CA, Savino S. Impact of early high flow nasal oxygen on diaphragmatic function and pulmonary complications after thoracic surgery: A randomized clinical trial. J Clin Anesth. 2025 Sep;106:111945. doi: 10.1016/j.jclinane.2025.111945. Epub 2025 Jul 23.
PubMed 40706477
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05532033
- Acronym / sponsor ID
- HFNCThoracic
- Conditions
- Diaphragm Injury, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 8 Sep 2022 (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.
Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula | Experimental | Device: High flow nasal cannulaTwo hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours |
| Standard oxygen therapy | Active comparator | Device: Facial maskTwo hours after extubation patients will received standard oxygenation therapy for 24 hours |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective thoracic surgery
Key exclusion criteria (5 listed)
- ASA score >3
- Body mass index > 35 kg/m2
- History of neuromuscular disease
- History of thoracic surgery
- Phrenic nerve paisy
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 |
|---|---|---|
| High flow nasal cannulaA device able to delivery high flow oxygen therapy | Device | high flow nasal cannula |
| Facial maskstandard oxygen therapy | Device | Standard oxygen therapy |
Primary outcome
Incidence of diaphragmatic dysfunction
Time frame: 24 hours after surgery
Ultrasound evaluation of diaphragmatic dysfunction
1 secondary outcome
Postoperative pulmonary complication
Time frame: 7 days after surgery
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 24 Oct 2023.
- Derived from this study: PubMed 40706477Fogagnolo A, Grasso S, Dres M, Azzolina D, Dalla Corte F, Dolci G, Tamburini N, De Paoli G, Murgolo F, Pedarzani E, Andalo A, Volta CA, Savino S. Impact of early high flow nasal oxygen on diaphragmatic function and pulmonary complications after thoracic surgery: A randomized clinical trial. J Clin Anesth. 2025 Sep;106:111945. doi: 10.1016/j.jclinane.2025.111945. Epub 2025 Jul 23.
- Individual participant dataSharing planned: Yes. Study dataset will be shared in anonymous form under reasonable request
Related trials for Diaphragm Injury
Active, not recruitingPhase 2
Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
Diaphragm Injury
RecruitingObservational study
Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients
Abdominal Injury, Pelvic Fracture
Active, not recruitingObservational study
Phrenic Identification in the ICU
Ventilator Lung, Ventilator-Induced Lung Injury
RecruitingObservational study
Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
Diaphragm Injury, Respiratory Failure
Recruiting
Feasibility of Reducing Respiratory Drive Using the Through-flow System
Respiratory Insufficiency, Diaphragm Injury
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?
A study testing High flow nasal cannula and Facial mask in people with Diaphragm Injury and Postoperative Complications, run by Università degli Studi di Ferrara at 1 site in Italy.
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 5 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 24 Oct 2023. 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 Italy. 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 diaphragmatic dysfunction (time frame: 24 hours after surgery). 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 NCT05532033, 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 24 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.