Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Oxygenation index measured using peripheral oxygen saturation index |
Other physiological outcome 4a (Peripheral oxygen saturation index = MAP * FiO2 *100 / SpO2; where MAP is mean airway pressure, FiO2 is fraction of inspired oxygen, SpO2 is peripheral oxygen saturation) |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Other |
Oxygenation index measured using arterial oxygenation index |
Other physiological outcome 4b (Arterial oxygenation index = MAP * FiO2 *100 / PaO2 ; where MAP is mean airway pressure, FiO2 is fraction of inspired oxygen, PaO2 is partial pressure of oxygen in arterial blood) |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Primary |
Adherence to the allocated ventilation mode among randomized/enrolled participants |
Main feasibility outcome |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Primary |
Proportion of time spent within the target range of carbon dioxide (normocarbia, defined as carbon dioxide = 35 mmHg or 4.5 kPa and = 45 mmHg or 6 kPa) measured using end-tidal carbon dioxide recorded every minute by the ventilation device |
Main physiological outcome |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month |
Secondary feasibility outcome 1 |
From date of recruitment start until date of recruitment end (assessed when n=60, anticipated through 6 months of recruitment period) |
|
| Secondary |
Reasons for protocol violations |
Other feasibility outcome 2a |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours since randomization) |
|
| Secondary |
Time from randomization to protocol violation |
Other feasibility outcome 2b |
From time of randomization until time of protocol violation (assessed up to 48 hours) |
|
| Secondary |
Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records |
Other feasibility outcome 3 |
From date of recruitment start until date of study end (assessed when n=60 and data has been extracted for all participants, anticipated through 8 months) |
|
| Secondary |
Time from ventilation start until screening |
Other feasibility outcome 4a |
From time of ventilation start until time of screening (assessed up to 48 hours) |
|
| Secondary |
Time from ventilation start until randomization |
Other feasibility outcome 4b |
From time of ventilation start until time of randomization (assessed up to 48 hours) |
|
| Secondary |
Time from consent until randomization |
Other feasibility outcome 5 |
From time of consent signed until time of randomization (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide |
Secondary physiological outcome 1a |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements |
Other physiological outcome 1b |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis |
Other physiological outcome 1c |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide |
Other physiological outcome 2a |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements |
Other physiological outcome 2b |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis |
Other physiological outcome 2c |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide |
Other physiological outcome 3a |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements |
Other physiological outcome 3b |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
| Secondary |
Time weighted average of hypo- and hypercarbia (i.e. carbon dioxide < 35 mmHg or 4.5 kPa; or >45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis |
Other physiological outcome 3c |
From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
|
