Tracheostomy is a medical procedure performed on the front of a persons neck. It is usedto create a connection between the persons trachea and a mechanical ventilator instead ofusing a tube going through the mouth into the trachea, oral intubation. Living with atracheostomy tube is less stressful compared to oral intubation and facilitate beingawake and the start of training on spontaneous ventilation in mechanically ventilatedpatients. Studies of the timing of tracheostomy are either severely affected bymethodological bias of to small to determine an effect. Thus, it is not known what theoptimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients.
The study hypothesis is that a strategy of tracheostomy during the second week of
mechanical ventilation yields more IMV-free days and lower mortality than continued
mechanical ventilation without tracheostomy, when efforts are made to neutralize immortal
time bias.
The hypothesis has been slightly changed to accommodate the methods change described
below.
Data sources Existing data provided for another project will be used.
Statistical methods:
A Markov multistate model with inverse probability weighting and landmark analyses at 7,
14, and 21 days from IMV start. The primary outcome is estimated ventilator-free days
alive at day 60; secondary analyses includes 60-day mortality.
The methods has been changed to multistate + landmark because the data did not support a
full cloning, censoring, weighing approach.
Procedure: Tracheostomy
Surgery for tracheostomy
Inclusion Criteria:
- Adult
- admitted to an intensive care unit in Sweden from 2020 to 2021
- Main discharge diagnosis COVID-19 (ICD-10, U07.1)
- Invasive mechanical ventilation
Exclusion Criteria:
- No Swedish personal identification number.
Uppsala University
Uppsala, Sweden
Björn Ahlström, PhD, Principal Investigator
Uppsala University