Clinical trial NCT03877172: High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study
Official title: High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery
Respiratory Failure
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Getinge Group
First posted: 2019-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory drive
timeFrame: Mean or median EAdi for both conditions (30 minutes each)
Secondary outcomes:
measure: Thickening fraction of the right hemidiaphragm
timeFrame: An ultrasound will be performed 25 minutes after starting each study condition
measure: Diaphragmatic excursion
timeFrame: An ultrasound will be performed 25 minutes after starting each study condition
measure: Oxygenation
timeFrame: An arterial blood sample will be obtained at the end (30 min) of each study condition
measure: Ventilation
timeFrame: An arterial blood sample will be obtained at the end (30 min) of each study condition
measure: Dyspnea
timeFrame: 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).
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Ricard Mellado Artigas, MD
role: PRINCIPAL_INVESTIGATOR
References: