Postural Changes and Severe COVID-19

NCT05679440 | Unknown

• 1 other identifier: RICU20230103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 remains a widespread global epidemic, increasing morbidity, mortality, healthcare resource consumption, and socio-economic burden on patients worldwide. The onset of COVID-19 ranges from mild, self-limiting respiratory disease to severe progressive pneumonia, mainly acute respiratory distress syndrome (ARDS), with critically ill patients requiring admission to the intensive care unit (ICU). Prone positioning has been shown to improve oxygenation and reduce complications and mortality in patients with severe ARDS. Prone position increases functional residual volume and chest wall elasticity, reduces dorsal segment edema in both lower lungs, facilitates uniform ventilation distribution, improves V/Q ratio, reduces alveolar shunts, and aids secretion drainage. In clinical practice, the prone position is mainly used for patients with diffuse bilateral lung lesions. However, it is less effective in unilateral or predominantly upper lung patients. Moreover, some patients are unable to tolerate prone ventilation. Therefore, we construct an individualized approach to postural oxygen therapy by guiding the patient's position based on the pulmonary imaging information. A study on the optimal ventilation position for patients with severe COVID-19 will be conducted at the Department of Respiratory and Critical Care Medicine, Wuhan Union Hospital. The investigators enrolled adult patients (without endotracheal intubation) diagnosed with severe COVID-19 requiring oxygen therapy from 2023.01.10 to 2024.01.10. Patients were grouped into control and intervention groups according to current treatment protocol and pulmonary imaging combined with patients' wishes and degree of postural tolerance. Patients in the intervention group were ventilated in different positions according to pulmonary imaging, including prone, left/right lateral, supine, semi-recumbent, and seated. In contrast, patients in the control group were ventilated comfortably according to the treatment principles and their wishes. The primary observation was 28-day mortality. Secondary observations were oxygenation index (PaO2/FiO2) before and after a position change, endotracheal intubation rate, duration of respiratory support, length of hospital stay, and comfort in position.

Conditions

COVID-19

Keywords

COVID-19; pulmonary imaging; prone position; lateral position; prognosis

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  Comparison of patients' deaths 28 days after admission.

  28 days

Secondary Outcomes (4)

• Endotracheal intubation rate

  From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months

• Length of respiratory support

  From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months

• Length of hospital stay

  From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months

• Hospital costs

  From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months

Study Arms (2)

Control group

NO INTERVENTION

Patients in the control group are ventilated in a comfortable position according to the principles of treatment and their wishes

Intervention group

EXPERIMENTAL

Patients are ventilated in prone position (for patients with bilateral lung lesions), left/right lateral position, semi-prone position (for patients with unilateral lung lesions or those who cannot tolerate prone ventilation, so that the diseased lung is above and the healthy lung is below), supine position (for patients who cannot tolerate prone ventilation or lateral ventilation, etc.) according to the pulmonary imaging data.

Behavioral: Postural interventions based on pulmonary imaging

Interventions

Postural interventions based on pulmonary imaging BEHAVIORAL

The main difference between the intervention group and the control group was the position during oxygen therapy. Patients in the intervention group were placed in the appropriate position for oxygen therapy according to pulmonary imaging, while patients in the control group were placed in the appropriate position for oxygen therapy according to conventional treatment principles and the patient's wishes.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Admitted with a confirmed diagnosis of COVID-19 severe pneumonia
• Patients without endotracheal intubation requiring high flow nasal cannula, non-invasive ventilator, mask, nasal cannula assisted ventilation
• Signed informed consent

You may not qualify if:

• Hemodynamic instability
• Unstable spinal fractures
• Unstable pelvic or long bone fractures
• Open abdominal wounds
• Late pregnancy
• Increased intracranial pressure due to a lesion in the head and neck that obstructs cerebral venous drainage.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (10)

• Tu GW, Liao YX, Li QY, Dong H, Yang LY, Zhang XY, Fu SZ, Wang RL. Prone positioning in high-flow nasal cannula for COVID-19 patients with severe hypoxemia: a pilot study. Ann Transl Med. 2020 May;8(9):598. doi: 10.21037/atm-20-3005. No abstract available.

  PMID: 32566624 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Liang WH, Guan WJ, Li CC, Li YM, Liang HR, Zhao Y, Liu XQ, Sang L, Chen RC, Tang CL, Wang T, Wang W, He QH, Chen ZS, Wong SS, Zanin M, Liu J, Xu X, Huang J, Li JF, Ou LM, Cheng B, Xiong S, Xie ZH, Ni ZY, Hu Y, Liu L, Shan H, Lei CL, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Cheng LL, Ye F, Li SY, Zheng JP, Zhang NF, Zhong NS, He JX. Clinical characteristics and outcomes of hospitalised patients with COVID-19 treated in Hubei (epicentre) and outside Hubei (non-epicentre): a nationwide analysis of China. Eur Respir J. 2020 Jun 4;55(6):2000562. doi: 10.1183/13993003.00562-2020. Print 2020 Jun.

  PMID: 32269086 BACKGROUND

• Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

  PMID: 32250385 BACKGROUND

• Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.

  PMID: 29068269 BACKGROUND

• Guerin C, Beuret P, Constantin JM, Bellani G, Garcia-Olivares P, Roca O, Meertens JH, Maia PA, Becher T, Peterson J, Larsson A, Gurjar M, Hajjej Z, Kovari F, Assiri AH, Mainas E, Hasan MS, Morocho-Tutillo DR, Baboi L, Chretien JM, Francois G, Ayzac L, Chen L, Brochard L, Mercat A; investigators of the APRONET Study Group, the REVA Network, the Reseau recherche de la Societe Francaise d'Anesthesie-Reanimation (SFAR-recherche) and the ESICM Trials Group. A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study. Intensive Care Med. 2018 Jan;44(1):22-37. doi: 10.1007/s00134-017-4996-5. Epub 2017 Dec 7.

  PMID: 29218379 BACKGROUND

• Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.

  PMID: 24134414 BACKGROUND

• Hewitt N, Bucknall T, Faraone NM. Lateral positioning for critically ill adult patients. Cochrane Database Syst Rev. 2016 May 12;2016(5):CD007205. doi: 10.1002/14651858.CD007205.pub2.

  PMID: 27169365 BACKGROUND

• Le MQ, Rosales R, Shapiro LT, Huang LY. The Down Side of Prone Positioning: The Case of a Coronavirus 2019 Survivor. Am J Phys Med Rehabil. 2020 Oct;99(10):870-872. doi: 10.1097/PHM.0000000000001530.

  PMID: 32657818 BACKGROUND

• Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, Du B, Brochard L, Qiu H. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294-1297. doi: 10.1164/rccm.202003-0527LE. No abstract available.

  PMID: 32200645 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaorong Wang, Ph.D., M.D.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaorong Wang, Ph.D., M.D.

CONTACT

+86 18627195231; rong-100@163.com

Zhuanyun Li, Ph.D., M.D.

CONTACT

+86 15199108915; lizy199299@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine physician

Model Details: In the intervention group, arterial blood gases, heart rate, blood pressure, finger pulse oxygen saturation and inhaled oxygen concentration were collected 30 minutes before ventilation in different positions according to pulmonary imaging data (Time 1). Patients are ventilated in prone position (for patients with bilateral lung lesions), left/right lateral position, semi-prone position (for patients with unilateral lung lesions or those who cannot tolerate prone ventilation, so that the diseased lung is above and the healthy lung is below), supine position (for patients who cannot tolerate prone ventilation or lateral ventilation, etc.) according to the pulmonary imaging data. Arterial blood gases, heart rate, blood pressure, finger pulse oxygen saturation, and inhaled oxygen concentration were collected again when the patient was ventilated in the different positions for 2 hours (Time 2).

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 11, 2023
• Study Start: January 10, 2023
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will share the data 6 months after the end of the study, which lasts for 6 months.
• Access Criteria: Data were obtained through the Principal Investigator of this study upon reasonable request.

Locations

CN (1)