High Flow Nasal Cannula and Diaphragmatic Function

NCT ID: NCT05532033

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-10-22

Brief Summary

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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

Detailed Description

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Conditions

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Diaphragm Injury Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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high flow nasal cannula

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

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

A device able to delivery high flow oxygen therapy

Standard oxygen therapy

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

Group Type ACTIVE_COMPARATOR

Facial mask

Intervention Type DEVICE

standard oxygen therapy

Interventions

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High flow nasal cannula

A device able to delivery high flow oxygen therapy

Intervention Type DEVICE

Facial mask

standard oxygen therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Alberto Fogagnolo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Università di Ferrara

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 40706477 (View on PubMed)

Other Identifiers

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HFNCThoracic

Identifier Type: -

Identifier Source: org_study_id

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