Prone Positioning During High Flow Oxygen Therapy in Acute Hypoxemic Respiratory Failure

NCT03095300 | Completed

• 1 other identifier: Optiprone
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background High-flow nasal cannula (NHF) are a promising tool for administering oxygen to critically ill patients with high respiratory demand. Prone positioning (PP) is a simple and cost-effective strategy that since 1980s has been used in mechanically ventilated patients with acute respiratory failure to treat oxygenation impairment. A large randomized study detected a relevant survival benefit by prone positioning in patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation and managed with the ARDS network PEEP-FiO2 table strategy. Theoretically, PP may benefit spontaneous breathing patients too, but data concerning its application in such context are limited to small case series and a retrospective study. The investigators designed a pilot feasibility study to assess the safety and efficacy of prone positioning in acute hypoxemic respiratory failure patients noninvasively treated with NHF. Methods Patients: 15 adult hypoxemic (PaO2/FiO2\<200 mmHg with respiratory rate greater than 25 breaths per minute) non-hypercapnic patients with acute respiratory failure. PaO2/FiO2 will be assessed while the patients is receiving 50 L/min of 50% oxygen via a standard face mask for a 15-minute monitoring period at study entry. Protocol Eligible patients will undergo NHF for 1 hour in the supine semi-recumbent position (baseline, BL). Afterwards, each enrolled patient will be placed in the prone position for 2 hours. After a 2-hour PP period, the patient will be rotated and will undergo 1 hour of NHF in the semi recumbent supine position (Supine step). Measurements Patient's demographics will be collected at study entry. At the end of the monitoring period, and then on a hourly basis the following data will be collected:

• Respiratory rate, SpO2, pH, PaCO2, PaO2, SaO2, PaO2/FiO2;
• Heart Rate, arterial blood pressure;
• Dyspnea, as defined by the VAS dyspnoea scale;
• Discomfort, as defined by a visual analogic scale (VAS) adapted to rate the procedural pain of ICU patients;
• End expiratory lung impedance (EELI), tidal volume distribution, global and regional lung dynamic strain (Change in lung impedence due to tidal volume/ELLI).
• Work of breathing, assessed by pressure-time product (PTP) of the esophageal pressure and inspiratory swings in this signal.
• Occurrence of pendelluft phenomenon The number of adverse events will be also recorded for each study step.

Conditions

Respiratory Failure With Hypoxia; Respiratory Failure Without Hypercapnia

Keywords

Prone Position; High-flow oxygen therapy

Outcome Measures

Primary Outcomes (2)

• Number of patients that undergo 2 hours of prone positioning without showing serious adverse events

  Number of patients that tolerate the procedure and complete the study according to the protocol without serious adverse events. The following will be considered serious adverse events: * Oxygen desaturations (SpO2 \<90%) * Episodes of haemodynamic instability (Systolic arterial pressure\<80 mmHg or FC\>120 BPM) * Displacement of central venous line, if documented * Displacement of arterial line, if documented

  2 hours

• Oxygenation

  Effects of prone position on oxygenation, defined by PaO2/FiO2 ratio

  2 hours

Secondary Outcomes (17)

• Respiratory rate

  2 hours

• Comfort

  2 hours

• Dyspnoea

  2 hours

• Global impedance-derived End-expiratory lung volume

  2 hours

• Regional impedance-derived End-expiratory lung volume

  2 hours

Interventions

Prone position PROCEDURE

Patients are rotated from the supine to the prone position for a period of 2 hours.

Eligibility Criteria

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

You may qualify if:

• Respiratory rate\>25 bpm and \<40 bpm.
• PaO2/FiO2\<200 mmHg measured after 15 minutes of heated and humidified 50% oxygen at a rate of 50 l/min via a non-rebreathing face mask. Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
• PaCO2 \<45mmHg
• Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA \> II or left ventricular ejection fraction \<50%).
• Body mass index \<30 kg/m2
• Absence of any contraindication to prone position.
• Written informed consent

You may not qualify if:

• Exacerbation of asthma or chronic obstructive pulmonary disease (COPD);
• Chest trauma
• Cardiogenic pulmonary oedema;
• Severe Neutropenia (\<500 WBC/mm3);
• Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed Shock
• Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
• Chronic kidney failure requiring dialysis before ICU admission;
• Glasgow coma scale \<13;
• Vomiting and/or upper gastrointestinal bleeding.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

General ICU, A. Gemelli hospital

Rome, 00100, Italy

Location

Related Publications (1)

• Grieco DL, Delle Cese L, Menga LS, Rosa T, Michi T, Lombardi G, Cesarano M, Giammatteo V, Bello G, Carelli S, Cutuli SL, Sandroni C, De Pascale G, Pesenti A, Maggiore SM, Antonelli M. Physiological effects of awake prone position in acute hypoxemic respiratory failure. Crit Care. 2023 Aug 17;27(1):315. doi: 10.1186/s13054-023-04600-9.

  PMID: 37592288 DERIVED

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

• Massimo Antonelli, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Full Professor, Director of the Department of Anesthesiology and Intensive Care Medicine

Model Details: Each enrolled patient will be monitored in the supine position for one hour, placed in the prone position for two hours and re-placed in the supine position for a final 1-hour step

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 29, 2017
• Study Start: October 1, 2018
• Primary Completion: June 20, 2020
• Study Completion: December 20, 2020
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

IT (1)