CClinicalTrials.gg
CompletedNCT05532033Updated Oct 24, 2023

High Flow Nasal Cannula and Diaphragmatic Function

An interventional study of High flow nasal cannula and Facial mask in Diaphragm Injury and Postoperative Complications, sponsored by Università degli Studi di Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by Università degli Studi di Ferrara · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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

02

Conditions studied

  • Diaphragm Injury
  • Postoperative Complications
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 116 is close to the median of 119 across 689 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Università degli Studi di Ferrara is the lead sponsor of 64 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for elective thoracic surgery

Exclusion criteria

Exclusion Criteria:

  • ASA score >3
  • Body mass index > 35 kg/m2
  • History of neuromuscular disease
  • History of thoracic surgery
  • Phrenic nerve paisy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    high flow nasal cannula

    Two hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours

    Device: High flow nasal cannula

  • Active comparator
    Standard oxygen therapy

    Two hours after extubation patients will received standard oxygenation therapy for 24 hours

    Device: Facial mask

Interventions

  • DeviceHigh flow nasal cannula

    A device able to delivery high flow oxygen therapy

  • DeviceFacial mask

    standard oxygen therapy

06

What researchers measure

Primary outcomes

  1. Incidence of diaphragmatic dysfunction

    Ultrasound evaluation of diaphragmatic dysfunction

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Postoperative pulmonary complication

    Incidence of postoperative pulmonary complication

    Time frame: 7 days after surgery

Other outcomes

  1. Days without oxygen support

    Time frame: 7 days

07

Study locations

1 site
  • Università di Ferrara
    Ferrara, 44121, Italy
08

References and documents

Individual participant data

Plan to share: Yes — Study dataset will be shared in anonymous form under reasonable request

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05532033
Lead sponsor
Università degli Studi di Ferrara
Responsible party
Alberto Fogagnolo (Principal investigator, Università degli Studi di Ferrara) — Principal investigator
First posted
Sep 8, 2022
Start date
Aug 9, 2022
Primary completion
Oct 15, 2023
Completion
Oct 22, 2023
Last update
Oct 24, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion