High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study

NCT ID: NCT03877172

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2020-12-31

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.

Conditions

Thoracic Surgery; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Face-mask oxygen therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

High-flow nasal cannula

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

Group Type: ACTIVE_COMPARATOR

High-flow nasal cannula

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Airvo 2, Fisher&Paykel.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Getinge Group

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Ricard Mellado Artigas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricard Mellado Artigas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic of Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ricard Mellado Artigas, MD

Role: CONTACT

rmartigas@gmail.com

+34 932275400 ext. 5558

Facility Contacts

Ricard Mellado Artigas, MD

Role: primary

rmartigas@gmail.com

+34 932275400 ext. 5558

Other Identifiers

HCB/2019/0049

Identifier Type: -

Identifier Source: org_study_id