Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346210
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-04-02
Brief Title:
Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tracheostomy is a medical procedure performed on the front of a persons neck It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea oral intubation Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect Thus it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients
Detailed Description:
Hypothesis It is hypothesised that timing of tracheostomy to day 9-11 is independently linked to a higher number of days alive without invasive mechanical ventilation and several secondary outcomes when adequate methods to neutralize waiting time and immortal time bias are used
Data sources Existing data provided for another project will be used
Statistical methods
A cohort study with a target trial emulation 1 on a dataset with cloned individuals assigned to different treatment strategies ie tracheostomy at different timings Censoring at deviation from assigned strategy or death 2 Adjustment for confounding will be used
Data sources Existing data provided for another project will be used
Statistical methods
A cohort study with a target trial emulation 1 on a dataset with cloned individuals assigned to different treatment strategies ie tracheostomy at different timings Censoring at deviation from assigned strategy or death 2 Adjustment for confounding will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None