High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure; Thoracic Surgery
• Intervention / Treatment: Device: High-flow nasal cannula

Detailed Description

Single centre, physiological crossover clinical trial in 40 patients in the immediate postoperative period after lung resection, equipped with a NAVA catheter to monitor diaphragm electrical activity (EAdi) and assess the effects that HFNC have on the respiratory drive and work of breathing as compared to conventional facemask oxygen therapy. Once in the postoperative care unit (PACU) and 1) after recovery from anaesthesia, 2) cardiorespiratory stable and 3) pain-free (see below), the intervention will start. The study will assess the effect of HFNC and oxygen via face mask on EAdi and diaphragm function, as measured by ultrasonography. HFNC and oxygen via face mask order will be randomized in a sequence (A-B or B-A) with the aid of a website (www.randomization.com). Each intervention will last for 30 minutes. The oxygen-inspired fraction (FiO2) will be adjusted to maintain a pulse oximetry (SpO2) between >92%. In the case of the high-flow nasal cannula, the study will be carried out with a flow of 50 L/min.

EAdi signal will be continuously monitored and its signal later exported to a laptop for further analysis. At the end of the 30-minute period, a blood sample will be obtained for gas analysis from the arterial line and the investigators will perform a diaphragm ultrasonography. Ultrasonography will consist of measurement of diaphragm thickness and thickening on the right side during quiet breathing and diaphragmatic excursion on both sides.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricard Mellado Artigas, MD; Phone Number: 5558 +34 932275400; Email: rmartigas@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: Ricard Mellado Artigas, MD; Phone Number: 5558 +34 932275400; Email: rmartigas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Face-mask oxygen therapy; Oxygen delivered through a conventional face mask to keep saturation above 92%.
Active Comparator: High-flow nasal cannula; High-flow nasal cannula delivered at 50 L/min and FiO2 adjusted to keep saturation above 92%.	Device: High-flow nasal cannula; 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.; Other Names: Airvo 2, Fisher&Paykel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickening fraction of the right hemidiaphragm	Diaphragm thickness will be assessed at end-inspiration and end-expiration and presented as percentage of change.	An ultrasound will be performed 25 minutes after starting each study condition
Diaphragmatic excursion	Diaphragmatic excursion will be assessed on each side and measured in millimeters	An ultrasound will be performed 25 minutes after starting each study condition
Oxygenation	Arterial oxygen pressure to inspired oxygen fraction ratio (PF ratio)	An arterial blood sample will be obtained at the end (30 min) of each study condition
Ventilation	Arterial pressure of carbon dioxide (CO2)	An arterial blood sample will be obtained at the end (30 min) of each study condition
Dyspnea	The presence of dyspnea will be assessed by a visual analog scale (VAS). This scale presents a range of discrete values from 0 to 10; with lower values indicating less symptoms and higher values indicating more symptoms. Participants will subjectively rate their own level of 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).

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Getinge Group
• Investigators: Principal Investigator: Ricard Mellado Artigas, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Anticipated): February 17, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HCB/2019/0049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No