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Changes in Lung Aeration and Inspiratory Effort With and Without Awake Prone

Primary Purpose

Respiratory Distress Syndrome, Ventilation Therapy; Complications

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
With and Without Awake Prone Positioning
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients (18-90 years) who have acute hypoxemic respiratory failure, requiring FIO2 > 0.4 to maintain SpO2 at 90-95% during HFNC at 50 L/min Exclusion Criteria: patients who need immediate intubation; refuse to participate in the study; unable to communicate; have contraindication to place the esophageal catheter; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.

Sites / Locations

  • Zhongshan hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

HFNC SP

HFNC PP

NIV SP

NIV PP

MC SP

MC PP

Arm Description

HFNC flow at 60 L/min or maximum tolerable flow at supine position

HFNC flow at 60 L/min or maximum tolerable flow at prone position

CPAP with full face mask at 10 cmH2O at supine position

CPAP with full face mask at 10 cmH2O at prone position

Mask oxygen at supine position

Mask oxygen at prone position

Outcomes

Primary Outcome Measures

The differences in lung homogeneity during HFNC
The differences in lung homogeneity (global inhomogeneity index) during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position
The differences in lung homogeneity during CPAP
The differences in lung homogeneity (global inhomogeneity index) during CPAP with full face mask at 8 cmH2O at supine and awake prone position

Secondary Outcome Measures

patient' comfort scores
during HFNC and CPAP treatment at supine and prone position, patient' comfort scores
work of breathing
the differences in WOB during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position

Full Information

First Posted
January 16, 2023
Last Updated
May 5, 2023
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05719103
Brief Title
Changes in Lung Aeration and Inspiratory Effort With and Without Awake Prone
Official Title
Changes in Lung Aeration and Inspiratory Effort During High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation With and Without Awake Prone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

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 investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of High-flow nasal cannula(HFNC) and (CPAP) on supine and prone position for COVID-19 or non-COVID-19 patients with acute hypoxemic respiratory failure (AHRF).
Detailed Description
Awake prone positioning (APP) for non-intubated patients has been reported to improve oxygenation for patients with acute hypoxemic respiratory failure (AHRF),particularly for patients with COVID-19 induced AHRF, APP has been shown to decrease the need of intubation.Similarly, APP with helmet continuous positive airway pressure (CPAP) enables a reduction in the work of breathing and an improvement in oxygenation and sensation of dyspnea in COVID-19-associated acute respiratory distress syndrome (ARDS). Moreover, among intubated patients with ARDS assessed by electro-impedance tomography (EIT), prone positioning was found to reduce alveolar overdistention and collapse, resulting in improvement of ventilation homogeneity.However, the effects of APP on the ventilation homogeneity and work of breathing for non-COVID-19 patients with AHRF remain unknown. High-flow nasal cannula (HFNC) has been proven to improve oxygenation and reduce intubation rate for patients with AHRF in multiple meta-analyses,and has been recommended to treat AHRF in several recently published guidelines.CPAP provides consistent level of positive end-expiratory pressure (PEEP), in comparison to variable level of PEEP generated by HFNC, thus CPAP was reported to have greater improvement of oxygenation than HFNC in 20 patients with AHRF, more importantly, they found that among patients who avoided intubation, the extent of oxygenation improvement was greater with HFNC+APP than with NIV+APP, in contrast, for patients who were intubated, the extent of oxygenation improvement was greater with NIV+APP than with HFNC+APP.This raised the concerns of the self-inflicted lung injury (SILI) generated by heterogenous aeration and large swings of transpulmonary pressure. Thus, the investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of HFNC and CPAP on supine and prone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Ventilation Therapy; Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFNC SP
Arm Type
Active Comparator
Arm Description
HFNC flow at 60 L/min or maximum tolerable flow at supine position
Arm Title
HFNC PP
Arm Type
Active Comparator
Arm Description
HFNC flow at 60 L/min or maximum tolerable flow at prone position
Arm Title
NIV SP
Arm Type
Active Comparator
Arm Description
CPAP with full face mask at 10 cmH2O at supine position
Arm Title
NIV PP
Arm Type
Active Comparator
Arm Description
CPAP with full face mask at 10 cmH2O at prone position
Arm Title
MC SP
Arm Type
Placebo Comparator
Arm Description
Mask oxygen at supine position
Arm Title
MC PP
Arm Type
Placebo Comparator
Arm Description
Mask oxygen at prone position
Intervention Type
Behavioral
Intervention Name(s)
With and Without Awake Prone Positioning
Other Intervention Name(s)
HFNC and NIV
Intervention Description
HFNC flow at 60 L/min or maximum tolerable flow at supine position HFNC flow at 60 L/min or maximum tolerable flow at prone position CPAP with full face mask at 10 cmH2O at supine position CPAP with full face mask at 10 cmH2O at prone position MC at supine position MC at prone position
Primary Outcome Measure Information:
Title
The differences in lung homogeneity during HFNC
Description
The differences in lung homogeneity (global inhomogeneity index) during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position
Time Frame
30 minutes
Title
The differences in lung homogeneity during CPAP
Description
The differences in lung homogeneity (global inhomogeneity index) during CPAP with full face mask at 8 cmH2O at supine and awake prone position
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
patient' comfort scores
Description
during HFNC and CPAP treatment at supine and prone position, patient' comfort scores
Time Frame
30 minutes
Title
work of breathing
Description
the differences in WOB during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients (18-90 years) who have acute hypoxemic respiratory failure, requiring FIO2 > 0.4 to maintain SpO2 at 90-95% during HFNC at 50 L/min Exclusion Criteria: patients who need immediate intubation; refuse to participate in the study; unable to communicate; have contraindication to place the esophageal catheter; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Zhong, MD, phD
Phone
021-65642662
Email
zhong.ming@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Zhong, MD, phD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Zhong

12. IPD Sharing Statement

Plan to Share IPD
No

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Changes in Lung Aeration and Inspiratory Effort With and Without Awake Prone

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