High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation

NCT05910788 | Unknown

• 1 other identifier: U1111-1292-9259
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study, is to clarify whether there is benefit from the perioperative use of HFNC in thoracic surgeries, from intubation to the postoperative period, evaluating hipoxemia during orotracheal intubation, immediate complications after intubation, mortality and in-hospital complications.

Conditions

Thoracic Surgery

Keywords

Thoracic surgery; High flow nasal cannula; Pulmonary complications

Outcome Measures

Primary Outcomes (2)

• Pulmonary Complications

  To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, when compared to the use of conventional oxygen therapy. extubation

  30 days

• Mortality

  To evaluate in-hospital postoperative mortality within 30 days.

  30 days

Secondary Outcomes (2)

• Incidence of hipoxemia

  5 minuts

• Complications after intubation and extubation

  5 minuts

Study Arms (2)

HFNC

ACTIVE COMPARATOR

The intervention group will receive HFNC therapy at induction of anesthesia. The intervention group will receive oxygen by 100% HFNC with a flow of 40 L.min-1 being increased to 70 L.min-1 during the period of apnea. A rapid sequence of orotracheal intubation will be performed, considering the time of apnea the moment of disappearance of the capnography line until the first ventilation after tube placement.

Device: high flow nasal cannula

Convencional oxygen therapy

NO INTERVENTION

Control group will receive conventional oxygen therapy by mask facial, with 100% oxygen and flow of 10 L.min-1.After surgery, patients who are extubated in the operating room or in theintensive care unit, will remain in the control and intervention groups and will receive therapy for conventional oxygen or HFNC, respectively.

Interventions

high flow nasal cannula DEVICE

The purpose of this intervention is clarify the benefit with the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications. is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications.

HFNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over 18 years of age who will undergo elective thoracic surgery and who have an ARISCAT score \> 26.

You may not qualify if:

• Patients who need urgent/emergency surgery, pregnant women, who do not have an ARISCAT score \> 26 and those who refuse to participate in the study.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Desejo Tarso Maioli

Bento Gonçalves, Rio Grande do Sul, 95700348, Brazil

RECRUITING

Related Publications (24)

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Central Study Contacts

Desire Maioli

CONTACT

55(54)999556129; desiremaioli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Main goal * To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, * To evaluate in-hospital postoperative mortality within 30 days. intubation) Secondary objectives * Assess the incidence of hypoxemia during orotracheal intubation/ extubation * Assess the incidence of immediate complications after intubation/ extubation(desaturation, failure of intubation/ extubation)

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 20, 2023
• Study Start: July 28, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)