NCT06757166

Brief Summary

To determine whether early endotracheal intubation compared to late endotracheal intubation affects clinical outcome (duration of invasive mechanical ventilation, mortality).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 1, 2018

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

7 years

First QC Date

December 23, 2024

Last Update Submit

January 2, 2025

Conditions

Target Trial Emulation, Invasive Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

  • 28-day RMTL of mortality

    Mortality restricted mean time lost (RMTL) over the 28-day period (area under the cumulative incidence function curve)

    28 days

  • 28-day mortality risk

    Mortality risk at day 28

    28 days

Interventions

endotracheal intubationPROCEDURE

endotracheal intubation for invasive mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the United Stated for which data is registered in the National Covid Cohort Collaborative (N3C).

You may qualify if:

  • Hospitalized (inpatient or ICU)
  • years or older
  • Hypoxemic respiratory failure: S/F\<250
  • Not yet intubated

You may not qualify if:

  • Do not intubate order
  • Presence of tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Centre

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Central Study Contacts

Carmen A.T. Reep, MSc

CONTACT

+31628164764c.reep@erasmusmc.nl

Evert-Jan Wils, PhD, MD

CONTACT

e.wils@franciscus.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate (MSc), Department of Intensive Care, Erasmus MC

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 3, 2025

Study Start

January 1, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)