A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure

NCT05698004 | Unknown

• 1 other identifier: prone positioning in ICU
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.

Conditions

Respiratory Failure, ICU

Outcome Measures

Primary Outcomes (1)

• Number of participants within intervention arm whom need endotracheal intubation.

  Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR\> 35/min., PaO2/FiO2\<200 mmHg, and respiratory acidosis (pH\<7.30)).

  30 days of randomization.

Secondary Outcomes (4)

• Number of days on a ventilator.

  30 days of randomization.

• mortality.

  60 days of randomization.

• Length of ICU stay in days.

  60 days of randomization.

• Length of hospital stay in days.

  60 days of randomization.

Study Arms (2)

Group-1: prone positioning + standard treatment

ACTIVE COMPARATOR

Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required.

Other: prone positioning

Group-2: Standard treatment only

NO INTERVENTION

Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position.

Interventions

prone positioning OTHER

The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU.

Group-1: prone positioning + standard treatment

Eligibility Criteria

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

You may qualify if:

• patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.

You may not qualify if:

• had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.

Sponsors & Collaborators

• Montaser Gamal Ahmed: lead

Related Publications (3)

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

• Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.

  PMID: 30872586 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

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sahar Refaat Mahmoud

  Assuit university hospital

  PRINCIPAL INVESTIGATOR

• Sarah Mohamed Hashem Hamza.

  Assuit university hospital

  PRINCIPAL INVESTIGATOR

• Emad Zareef

  Assuit university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Montaser Gamal

CONTACT

01008951058; montaser_zahran@yahoo.com

Aliae AR Mohamed Hussein

CONTACT

aliaehussein@gamil.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Model Details: Patients with acute hypoxemic respiratory failure attending the participating centres will receive either prone positioning + standard treatment or standard treatment only. All new acute hypoxemic respiratory failure patients will receive prone positioning + standard treatment for the first two weeks of the study. During the following two weeks, all new patients will receive standard treatment only. These cycles will be repeated until completion the study.

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 26, 2023

Record last verified: 2022-12