HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

NCT05990101 | Recruiting

• 1 other identifier: 2023/6-1517-981
• Study Type: interventional
• Target: 262
• Locations: 2 countries
• Sites: 4

Brief Summary

The goal of this prospective multi-centre randomised controlled trial is to determine if addition of awake prone positioning to standard oxygen, high flow oxygen therapy and non-invasive ventilation may reduce the rates of endotracheal intubation and mechanical ventilation.

Conditions

Respiratory Failure; Hypoxemia

Keywords

Awake prone; Respiratory failure; ARDS; Hypoxaemia

Outcome Measures

Primary Outcomes (1)

• Rate of endotracheal intubation

  Incidence of endotracheal intubation in both groups

  Within 30 days of randomisation

Secondary Outcomes (5)

• Mortality

  Within 1 year of randomisation

• Duration of mechanical ventilation

  Within 30 days of randomisation

• Length of intensive care unit and hospital stay

  Within 30 days of randomisation

• One year mortality

  Within 1 year of randomisation

• Health related quality of life

  Within 1 year of randomisation

Other Outcomes (1)

• Tolerance of awake prone positioning

  Within 72 hours of randomisation

Study Arms (2)

APP group

EXPERIMENTAL

Awake prone position (APP) for 4 or more hours per day in addition to standard care for the first 72 hours from randomisation. After the initial period, use of APP is at discretion of the treating clinician. Awake prone can be discontinued earlier if patients meets pre-specified criteria of sustained improvement.

Behavioral: Awake prone position (APP)

Control group

NO INTERVENTION

Standard care excluding APP

Interventions

Awake prone position (APP) BEHAVIORAL

Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.

APP group

Eligibility Criteria

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

You may qualify if:

• Adult patients admitted to intensive care unit for acute hypoxemic respiratory failure.
• Acute hypoxemic respiratory failure is defined by respiratory rate ≥25 breaths/min, and partial pressure of oxygen in the arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ≤300 mm Hg or oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio \<235 while spontaneously breathing under standard oxygen with oxygen flow rate of at least 10 L/min, high flow oxygen therapy or non-invasive ventilation. For patients under standard oxygen, FiO2 is calculated according to the following formula: FiO2=0.21 + 0.03 per litre of supplemental oxygen.
• Informed consent

You may not qualify if:

• impaired consciousness - Glasgow coma score \<14;
• inability to cooperate or prone position intolerance;
• immediate indications for endotracheal intubation;
• patients with contraindication to high flow oxygen therapy (HFOT) or non-invasive ventilation (NIV);
• Partial pressure of carbon dioxide (PaCO2) above 50 mm Hg and quantitative measure of the acidity (pH) \<7,3;
• vasopressor dose \>0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure \>90 mmHg;
• Covid-19 positive

Sponsors & Collaborators

• Vilnius University: lead
• Vilnius University Hospital Santaros Klinikos: collaborator

Study Sites (4)

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

NOT YET RECRUITING

Republican Vilnius University Hospital

Vilnius, 04130, Lithuania

NOT YET RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Barking, Havering and Redbridge University Hospitals NHS Trust

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ieva Jovaisiene, Dr

  Vilnius University Hospital Santaros Klinikos

  PRINCIPAL INVESTIGATOR

• Mandeep K Phull, Dr

  Barking, Havering and Redbridge University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Tomas Jovaisa, Prof

  Vilnius University Hospital Santaros Klinikos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Jovaisa, Prof

CONTACT

+37062697567; tomas.jovaisa@santa.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: By the nature of the awake prone intervention, it will not be possible to blind clinicians; however, interventions will be blinded to data analysts and outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be allocated to the awake prone or standard care groups on a 1:1 ratio.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 14, 2023
• Study Start: May 12, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); LI (3)