High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study
Primary Purpose
Thoracic Surgery, Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High-flow nasal cannula
Sponsored by
About this trial
This is an interventional prevention trial for Thoracic Surgery
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
Sites / Locations
- Hospital Clinic of BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Face-mask oxygen therapy
High-flow nasal cannula
Arm Description
Oxygen delivered through a conventional face mask to keep saturation above 92%.
High-flow nasal cannula delivered at 50 L/min and FiO2 adjusted to keep saturation above 92%.
Outcomes
Primary Outcome Measures
Respiratory drive
Respiratory drive will be assessed as maximal EMG activity during each respiratory cycle (peak EAdi of the NAVA catheter)
Secondary Outcome Measures
Thickening fraction of the right hemidiaphragm
Diaphragm thickness will be assessed at end-inspiration and end-expiration and presented as percentage of change.
Diaphragmatic excursion
Diaphragmatic excursion will be assessed on each side and measured in millimeters
Oxygenation
Arterial oxygen pressure to inspired oxygen fraction ratio (PF ratio)
Ventilation
Arterial pressure of carbon dioxide (CO2)
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.
Full Information
NCT ID
NCT03877172
First Posted
March 12, 2019
Last Updated
February 10, 2020
Sponsor
Hospital Clinic of Barcelona
Collaborators
Getinge Group
1. Study Identification
Unique Protocol Identification Number
NCT03877172
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Getinge Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Respiratory Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Face-mask oxygen therapy
Arm Type
No Intervention
Arm Description
Oxygen delivered through a conventional face mask to keep saturation above 92%.
Arm Title
High-flow nasal cannula
Arm Type
Active Comparator
Arm Description
High-flow nasal cannula delivered at 50 L/min and FiO2 adjusted to keep saturation above 92%.
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula
Other Intervention Name(s)
Airvo 2, Fisher&Paykel.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory drive
Description
Respiratory drive will be assessed as maximal EMG activity during each respiratory cycle (peak EAdi of the NAVA catheter)
Time Frame
Mean or median EAdi for both conditions (30 minutes each)
Secondary Outcome Measure Information:
Title
Thickening fraction of the right hemidiaphragm
Description
Diaphragm thickness will be assessed at end-inspiration and end-expiration and presented as percentage of change.
Time Frame
An ultrasound will be performed 25 minutes after starting each study condition
Title
Diaphragmatic excursion
Description
Diaphragmatic excursion will be assessed on each side and measured in millimeters
Time Frame
An ultrasound will be performed 25 minutes after starting each study condition
Title
Oxygenation
Description
Arterial oxygen pressure to inspired oxygen fraction ratio (PF ratio)
Time Frame
An arterial blood sample will be obtained at the end (30 min) of each study condition
Title
Ventilation
Description
Arterial pressure of carbon dioxide (CO2)
Time Frame
An arterial blood sample will be obtained at the end (30 min) of each study condition
Title
Dyspnea
Description
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.
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricard Mellado Artigas, MD
Phone
+34 932275400
Ext
5558
Email
rmartigas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricard Mellado Artigas, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricard Mellado Artigas, MD
Phone
+34 932275400
Ext
5558
Email
rmartigas@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study
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