NCT06996197

Brief Summary

Investigators performed a retrospective observational single-centre study in a cohort of COVID-19 patients with AHRF who required NIV support and intensive care unit (ICU) admission from May 2021 to January 2022. A BIA assessment was performed within the first 24 hours after NIV onset. Patient characteristics, severity scores, HACOR score, NIV settings, and mortality were recorded. Cox-hazard multivariate analysis was used to assess the association between BIA parameters and NIV failure, adjusting for potential covariates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 19, 2025

Last Update Submit

May 29, 2025

Conditions

Hypoxemic Acute Respiratory FailureNon Invasive Ventilation (NIV)Bioimpedance Measurement Capacity

Keywords

bioimpedanciometrynon invasive mechanical ventilationhypoxemic acute respiratory failureARDS

Outcome Measures

Primary Outcomes (1)

  • NIV failure

    Rate of patients that required endotracheal intubation after initiating NIV support.

    through study completion, an average of 1 month.

Secondary Outcomes (1)

  • Hospital mortality

    through study completion, an average of 1 month.

Study Arms (1)

Bioimpedanciometry

EXPERIMENTAL

BIA parameters were measured within the first 24h of ICU admission, once the patient was receiving NIV support.

Other: Bioimpedance analysis

Interventions

Bioimpedance analysisOTHER

BIA parameters were measured within the first 24h of ICU admission, once the patient was receiving NIV support.

Bioimpedanciometry

Eligibility Criteria

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

You may qualify if:

  • Moderate-to-severe Acute Hypoxemic Respiratory Failure (PaO2 /FiO2 \< 200mmHg) due to respiratory infection who underwent NIV support for at least 24h.

You may not qualify if:

  • Presence of electrical implants, wounds or skin damage at the designated electrode sites or the inability to perform BIA.
  • Patients who met criteria for immediate intubation upon ICU admission were also excluded.
  • Other circumstances or clinical conditions at the discretion of the investigator that precluded the participation of the patient in the study were also considered (i.e., limitation of therapeutic effort and poor prognosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

  • Woo HY, Oh SY, Lee H, Ryu HG. Evaluation of the association between decreased skeletal muscle mass and extubation failure after long-term mechanical ventilation. Clin Nutr. 2020 Sep;39(9):2764-2770. doi: 10.1016/j.clnu.2019.12.002. Epub 2019 Dec 14.

    PMID: 31917051BACKGROUND

  • Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

    PMID: 28860265BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 30, 2025

Study Start

May 12, 2021

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

After publishing results data will be made accesible to all researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publishing results data will be made accesible to all researchers for two whole years.
Access Criteria
Open access platform
More information

Locations

ES(2)