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

NCT03095300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-03

No results posted yet for this study

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

Interventions

PROCEDURE

Prone position

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

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Massimo Antonelli, MD · Catholic University of the Sacred Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-06-20
Completion
2020-12-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095300 on ClinicalTrials.gov