High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study

NCT03877172 | Unknown

• 1 other identifier: HCB/2019/0049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the role that high-flow nasal cannulas (HFNC) have on respiratory drive, work of breathing and neuromuscular efficiency after lung resection surgery. The main question the investigators aim to answer is whether HFNC decrease respiratory drive by at least 15% in these patients, assessed by a special diaphragmatic electromyography (EMG) device (NAVA catheter). In order, to perform this study, the investigators will perform a physiological study in 40 patients. These patients will be assessed in the immediate postoperative period and HFNC will be compared to conventional face-mask therapy.

Conditions

Thoracic Surgery; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Respiratory drive

  Respiratory drive will be assessed as maximal EMG activity during each respiratory cycle (peak EAdi of the NAVA catheter)

  Mean or median EAdi for both conditions (30 minutes each)

Secondary Outcomes (5)

• Thickening fraction of the right hemidiaphragm

  An ultrasound will be performed 25 minutes after starting each study condition

• Diaphragmatic excursion

  An ultrasound will be performed 25 minutes after starting each study condition

• Oxygenation

  An arterial blood sample will be obtained at the end (30 min) of each study condition

• Ventilation

  An arterial blood sample will be obtained at the end (30 min) of each study condition

• Dyspnea

  Dyspnea presence by VAS will be assessed at the 30-minute mark of each condition (end of each condition) and will evaluate dyspnea for the whole condition (30 minutes).

Study Arms (2)

Face-mask oxygen therapy

NO INTERVENTION

Oxygen delivered through a conventional face mask to keep saturation above 92%.

High-flow nasal cannula

ACTIVE COMPARATOR

High-flow nasal cannula delivered at 50 L/min and FiO2 adjusted to keep saturation above 92%.

Device: High-flow nasal cannula

Interventions

High-flow nasal cannula DEVICE

To provide high-flow nasal cannula in the immediate postoperative period after lung resection surgery as compared to conventional face-mask therapy, in a randomized sequence, for 30 minutes.

Also known as: Airvo 2, Fisher&Paykel.

High-flow nasal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects submitted to lung resection with an expected mechanical ventilation time of more than 180 minutes.

You may not qualify if:

• Patient refusal to participate
• Contraindications to nasogastric tube placement (i.e. oesophageal varices)
• Patients less than 18 years old
• Pregnancy
• Neuromuscular disease
• Prior thoracic surgery

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Getinge Group: collaborator

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ricard Mellado Artigas, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricard Mellado Artigas, MD

CONTACT

+34 932275400; rmartigas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: February 17, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

ES (1)