Back to resultsHigh Flow Nasal Cannula and Diaphragmatic Function
Primary Purpose
Diaphragm Injury, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High flow nasal cannula
Facial mask
Sponsored by
About this trial
This is an interventional prevention trial for Diaphragm Injury
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for elective thoracic surgery
Exclusion Criteria:
- ASA score >3
- Body mass index > 35 kg/m2
- History of neuromuscular disease
- History of thoracic surgery
- Phrenic nerve paisy
Sites / Locations
- Università di Ferrara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high flow nasal cannula
Standard oxygen therapy
Arm Description
Two hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours
Two hours after extubation patients will received standard oxygenation therapy for 24 hours
Outcomes
Primary Outcome Measures
Incidence of diaphragmatic dysfunction
Ultrasound evaluation of diaphragmatic dysfunction
Secondary Outcome Measures
Postoperative pulmonary complication
Incidence of postoperative pulmonary complication
Full Information
NCT ID
NCT05532033
First Posted
August 9, 2022
Last Updated
October 22, 2023
Sponsor
Università degli Studi di Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT05532033
Brief Title
High Flow Nasal Cannula and Diaphragmatic Function
Official Title
Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Actual)
Study Completion Date
October 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Ferrara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Injury, Postoperative Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high flow nasal cannula
Arm Type
Experimental
Arm Description
Two hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours
Arm Title
Standard oxygen therapy
Arm Type
Active Comparator
Arm Description
Two hours after extubation patients will received standard oxygenation therapy for 24 hours
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
A device able to delivery high flow oxygen therapy
Intervention Type
Device
Intervention Name(s)
Facial mask
Intervention Description
standard oxygen therapy
Primary Outcome Measure Information:
Title
Incidence of diaphragmatic dysfunction
Description
Ultrasound evaluation of diaphragmatic dysfunction
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pulmonary complication
Description
Incidence of postoperative pulmonary complication
Time Frame
7 days after surgery
Other Pre-specified Outcome Measures:
Title
Days without oxygen support
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for elective thoracic surgery
Exclusion Criteria:
ASA score >3
Body mass index > 35 kg/m2
History of neuromuscular disease
History of thoracic surgery
Phrenic nerve paisy
Facility Information:
Facility Name
Università di Ferrara
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study dataset will be shared in anonymous form under reasonable request
Learn more about this trial
High Flow Nasal Cannula and Diaphragmatic Function
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