A Physiological Study to Assess Awake Prone Positioning and Respiratory Support in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Physiological Study to Assess the Effects of Awake Prone Positioning in Healthy Volunteers Under Different Respiratory Support: A Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512585
• Other study ID #: APP-002
• Status: Completed
• Phase: N/A
• Start date: August 28, 2022
• Est. completion date: November 27, 2022

Study information

• Verified date: December 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Awake prone positioning (APP) has been proven to reduce the intubation rate for patients with COVID-19-induced hypoxemic respiratory failure. Our recent meta-analysis found APP was only effective for patients who were treated by high-flow nasal cannula (HFNC), not for patients using conventional oxygen therapy (COT).In a recent multicenter RCT, Perkins and colleagues reported that continuous positive airway pressure (CPAP) was superior to HFNC and conventional oxygen therapy in reducing intubation rate. Thus, it is essential to evaluate the physiological mechanism of APP under different respiratory supports, such as COT, HFNC, or CPAP.

We hypothesize that HFNC or CPAP is more effective when combined with APP than COT combined with APP. Electrical impedance tomography (EIT imaging) has been broadly utilized to assess patient ventilation homogeneity and respiratory volume monitor (RVM) has been used to evaluate patient's tidal volumes breath-by-breath. In this study, 20 healthy volunteers will use different respiratory support devices (HFNC, CPAP, and COT) in different settings and their combinations withAPP in a random sequence, assessed by EIT and RVM.

Description:

Awake prone positioning (APP) has been proven to reduce the intubation rate for patients with COVID-19-induced hypoxemic respiratory failure. Our recent meta-analysis found APP was only effective for patients who were treated by high-flow nasal cannula (HFNC), not for patients using conventional oxygen therapy (COT).In a recent multicenter RCT, Perkins and colleagues reported that continuous positive airway pressure (CPAP) was superior to HFNC and conventional oxygen therapy in reducing intubation rate. Thus, it is essential to evaluate the physiological mechanism of APP under different respiratory supports, such as COT, HFNC, or CPAP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 27, 2022
• Est. primary completion date: November 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

healthy adults aged between 21 to 65 years

Exclusion Criteria:

• Tested COVID positive within 21 days, or has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit.

• Currently have the following symptoms: sore throat, fever, coughing, shortness of breath, loss of smell or taste

• Non-English speaking

• Has any of the following diseases: asthma, chronic obstructive pulmonary disease, Uncontrolled Diabetes, hypertension, or untreated thyroid disease

• and spinal cord injury.

• Claustrophobia

• Pregnancy

• Pacemaker (EIT contraindication)

• face or chest skin injury that could not use a facemask or the electrode belt

• could not tolerate prone positioning for one hour

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure)
in this group, healthy subjects will stay in prone position for 20 mins with respiratory support of high-flow nasal cannula or CPAP

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Chiumello D, Chiodaroli E, Coppola S, Cappio Borlino S, Granata C, Pitimada M, Wendel Garcia PD. Awake prone position reduces work of breathing in patients with COVID-19 ARDS supported by CPAP. Ann Intensive Care. 2021 Dec 20;11(1):179. doi: 10.1186/s13613-021-00967-6. — View Citation

Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone — View Citation

Li J, Luo J, Pavlov I, Perez Y, Tan W, Roca O, Tavernier E, Kharat A, McNicholas B, Ibarra-Estrada M, Vines DL, Bosch NA, Rampon G, Simpson SQ, Walkey AJ, Fralick M, Verma A, Razak F, Harris T, Laffey JG, Guerin C, Ehrmann S; Awake Prone Positioning Meta- — View Citation

Liu L, Xie J, Wang C, Zhao Z, Chong Y, Yuan X, Qiu H, Zhao M, Yang Y, Slutsky AS. Prone position improves lung ventilation-perfusion matching in non-intubated COVID-19 patients: a prospective physiologic study. Crit Care. 2022 Jun 29;26(1):193. doi: 10.1186/s13054-022-04069-y. No abstract available. — View Citation

Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31. — View Citation

Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028. — View Citation

Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilation distribution assessed by EIT	Regional ventilation assessed by regional tidal impedance variations relative to global tidal impedance variation (?zROI/?zglobal) obtained by electrical impedance tomography (EIT)	20 minutes
Secondary	tidal volume	the gas volume during tidal breathing	20 minutes
Secondary	respiratory rates	breathing frequency during tidal breathing	20 minutes
Secondary	comfort	subject's comfort which will be assessed by a 1-10 scale	20 minutes