High Flow Nasal Cannula and Diaphragmatic Function
Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery
1 other identifier
interventional
116
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2022
CompletedStudy Start
First participant enrolled
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2023
CompletedOctober 24, 2023
October 1, 2023
1.2 years
August 9, 2022
October 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of diaphragmatic dysfunction
Ultrasound evaluation of diaphragmatic dysfunction
24 hours after surgery
Secondary Outcomes (1)
Postoperative pulmonary complication
7 days after surgery
Other Outcomes (1)
Days without oxygen support
7 days
Study Arms (2)
high flow nasal cannula
EXPERIMENTALTwo hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours
Standard oxygen therapy
ACTIVE COMPARATORTwo hours after extubation patients will received standard oxygenation therapy for 24 hours
Interventions
A device able to delivery high flow oxygen therapy
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective thoracic surgery
You may not qualify if:
- ASA score \>3
- Body mass index \> 35 kg/m2
- History of neuromuscular disease
- History of thoracic surgery
- Phrenic nerve paisy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Università di Ferrara
Ferrara, 44121, Italy
Related Publications (1)
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.
PMID: 40706477DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 9, 2022
First Posted
September 8, 2022
Study Start
August 9, 2022
Primary Completion
October 15, 2023
Study Completion
October 22, 2023
Last Updated
October 24, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Study dataset will be shared in anonymous form under reasonable request