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

NCT ID: NCT05719103

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-12-31

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.

Conditions

Respiratory Distress Syndrome; Ventilation Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HFNC SP

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

Group Type: ACTIVE_COMPARATOR

With and Without Awake Prone Positioning

Intervention Type: BEHAVIORAL

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

HFNC PP

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

Group Type: ACTIVE_COMPARATOR

With and Without Awake Prone Positioning

Intervention Type: BEHAVIORAL

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

NIV SP

CPAP with full face mask at 10 cmH2O at supine position

Group Type: ACTIVE_COMPARATOR

With and Without Awake Prone Positioning

Intervention Type: BEHAVIORAL

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

NIV PP

CPAP with full face mask at 10 cmH2O at prone position

Group Type: ACTIVE_COMPARATOR

With and Without Awake Prone Positioning

Intervention Type: BEHAVIORAL

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

MC SP

Mask oxygen at supine position

Group Type: PLACEBO_COMPARATOR

With and Without Awake Prone Positioning

Intervention Type: BEHAVIORAL

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

MC PP

Mask oxygen at prone position

Group Type: PLACEBO_COMPARATOR

With and Without Awake Prone Positioning

Intervention Type: BEHAVIORAL

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

Interventions

With and Without Awake Prone Positioning

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

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

3. CPAP with full face mask at 10 cmH2O at supine position

4. CPAP with full face mask at 10 cmH2O at prone position

5. MC at supine position

6. MC at prone position

Intervention Type: BEHAVIORAL

Other Intervention Names

HFNC and NIV

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Zhong, MD, phD

Role: STUDY_CHAIR

Fudan University

Locations

Zhongshan hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Zhong, MD, phD

Role: CONTACT

zhong.ming@zs-hospital.sh.cn

021-65642662

Facility Contacts

Ming Zhong

Role: primary

Other Identifiers

APP-HF-NIV

Identifier Type: -

Identifier Source: org_study_id