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

NCT05719103 | Unknown

• 1 other identifier: APP-HF-NIV
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Distress Syndrome; Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• patient' comfort scores

  30 minutes

• work of breathing

  30 minutes

Study Arms (6)

HFNC SP

ACTIVE COMPARATOR

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

Behavioral: With and Without Awake Prone Positioning

HFNC PP

ACTIVE COMPARATOR

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

Behavioral: With and Without Awake Prone Positioning

NIV SP

ACTIVE COMPARATOR

CPAP with full face mask at 10 cmH2O at supine position

Behavioral: With and Without Awake Prone Positioning

NIV PP

ACTIVE COMPARATOR

CPAP with full face mask at 10 cmH2O at prone position

Behavioral: With and Without Awake Prone Positioning

MC SP

PLACEBO COMPARATOR

Mask oxygen at supine position

Behavioral: With and Without Awake Prone Positioning

MC PP

PLACEBO COMPARATOR

Mask oxygen at prone position

Behavioral: With and Without Awake Prone Positioning

Interventions

With and Without Awake Prone Positioning 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

Also known as: HFNC and NIV

HFNC PP; HFNC SP; MC PP; MC SP; NIV PP; NIV SP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ming Zhong, MD, phD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Ming Zhong, MD, phD

CONTACT

021-65642662; zhong.ming@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 8, 2023
• Study Start: January 9, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)