NCT07750717

Brief Summary

The diagnosis of Acute Respiratory Distress Syndrome (ARDS) is a syndromic diagnosis that groups together patients who may have very different prognoses and respond differently to the same therapies. Additionally, non-invasive ventilation (NIV) has shown highly contrasting results in the early management of ARDS. One of the predictive criteria for NIV failure is an excessively high tidal volume during non-invasive ventilation. SPIRALI is a pilot study evaluating the relevance of a respiratory physiology parameter, the tidal volume relative to the theoretical ideal body weigh, in the phenotypic classification of non-intubated ARDS patients. In this initial approach, the investigators will compare the tidal volume during high-flow oxygen therapy with the tidal volume obtained under NIV (after applying a settings optimization algorithm). The investigators hypothesize that if tidal volume is linked to each situation, the same patients will exhibit a high tidal volume both during spontaneous ventilation and under NIV.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

Same day

First QC Date

May 19, 2026

Last Update Submit

August 5, 2026

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV

    Tidal volume measured by a hand-held spirometer in spontaneous ventilation and exhaled tidal volume measured by the ventilator in NIV after optimization of the settings

    At T2 and T3, with measurement of VT using a portable spirometer and NIV on the day of enrollment. T1,T2,T3<1h30min

Study Arms (1)

tidal volume in spontaneous ventilation and NIV

EXPERIMENTAL
Device: Hand-held spirometerDevice: NIV

Interventions

Hand-held spirometerDEVICE

spontaneous ventilation using a hand-held spirometer

tidal volume in spontaneous ventilation and NIV
NIVDEVICE

NIV with predefined settings and then with optimized settings

tidal volume in spontaneous ventilation and NIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18 years of age;
  • Patient hospitalized in intensive care for less than 24 hours;
  • Patient with severe hypoxemic acute respiratory failure characterized by a PaO2/FiO2 ratio \< 300 mmHg and \> 150 mmHg under high-flow oxygen therapy at 60 L/min;
  • Patient able to cooperate with the spirometry test;
  • Patient able to follow the protocol and having given their informed written consent to participate in the study;
  • Patient affiliated with the social security system or entitled to benefits;

You may not qualify if:

  • Patients with an indication for intubation;
  • Patients with a contraindication for or who refuse NIV;
  • Patients with hemodynamic instability requiring vasopressor support greater than 0.25 μg/kg/min of norepinephrine;
  • Patients with a Glasgow score \< 15;
  • Patients with hypercapnia (PaCO2 \> 45 mmHg);
  • Patients with a PaO2/FiO2 ratio \< 150 mmHg;
  • Patients with cardiogenic pulmonary edema;
  • Patients who have already undergone a session of NIV in intensive care during this stay;
  • Patients with chronic respiratory failure (home oxygen therapy or home non-invasive ventilation (excluding indications solely for sleep apnea syndrome));
  • Patients who have recently had a pneumothorax;
  • Patients who have recently undergone eye surgery (e.g., cataract surgery) or throat surgery;
  • Patients with significant arterial disease: recent heart attack, pulmonary embolism, poorly controlled hypertension despite treatment, etc.
  • Patients already included in the study;
  • Pregnant women, women in labor, or women who are breastfeeding;
  • Patients under guardianship, conservatorship, or deprived of their liberty;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu

Nantes, 44093, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Gwenhaël COLIN, Dr

    Centre Hospitalier Départemental Vendée

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura SOULARD

CONTACT

02.51.08.05.82laura.soulard@chd-vendee.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

August 6, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 1, 2029

Last Updated

August 6, 2026

Record last verified: 2026-08

Locations

FR(1)