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

Changes in Lung Aeration and Inspiratory Effort During High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation With and Without Awake Prone

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).

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress Syndrome; Ventilation Therapy; Complications
• Intervention / Treatment: Behavioral: With and Without Awake Prone Positioning

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Zhong, MD, phD; Phone Number: 021-65642662; Email: zhong.ming@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan Hospital
    • Contact: Ming Zhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HFNC SP; HFNC flow at 60 L/min or maximum tolerable flow at supine position	Behavioral: With and Without Awake Prone Positioning; 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; Other Names: HFNC and NIV
Active Comparator: HFNC PP; HFNC flow at 60 L/min or maximum tolerable flow at prone position	Behavioral: With and Without Awake Prone Positioning; 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; Other Names: HFNC and NIV
Active Comparator: NIV SP; CPAP with full face mask at 10 cmH2O at supine position	Behavioral: With and Without Awake Prone Positioning; 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; Other Names: HFNC and NIV
Active Comparator: NIV PP; CPAP with full face mask at 10 cmH2O at prone position	Behavioral: With and Without Awake Prone Positioning; 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; Other Names: HFNC and NIV
Placebo Comparator: MC SP; Mask oxygen at supine position	Behavioral: With and Without Awake Prone Positioning; 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; Other Names: HFNC and NIV
Placebo Comparator: MC PP; Mask oxygen at prone position	Behavioral: With and Without Awake Prone Positioning; 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; Other Names: HFNC and NIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 minutes
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	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
work of breathing	the differences in WOB during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position	30 minutes
patient' comfort scores	during HFNC and CPAP treatment at supine and prone position, patient' comfort scores	30 minutes

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Ming Zhong, MD, phD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: APP-HF-NIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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