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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05719103

Collaborator

(none)

Enrollment

Location

Arms

35.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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 non-COVID-19 patients with acute hypoxemic respiratory failure (AHRF).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome Ventilation Therapy; Complications	Behavioral: With and Without Awake Prone Positioning	N/A

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 an

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 9, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

work of breathing [30 minutes]
the differences in WOB during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position

Secondary Outcome Measures

The differences in lung homogeneity during HFNC [30 minutes]
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 [30 minutes]
The differences in lung homogeneity (global inhomogeneity index) during CPAP with full face mask at 8 cmH2O at supine and awake prone position
patient' comfort scores [30 minutes]
during HFNC and CPAP treatment at supine and prone position, patient' comfort scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan hospital	Shanghai		China	200032

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Study Chair: Ming Zhong, MD, phD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05719103

Other Study ID Numbers:

APP-HF-NIV

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Feb 8, 2023