The present study aims at comparing a ventilation strategy with a lower tidal volume and a higher respiratory rate with ventilation using a higher tidal volume and a lower respiratory rate in ICU patients without moderate or severe ARDS.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of ventilator-free days at day 28 after ICU admission.
Secondary outcome
ICU and hospital length of stay (LOS) (follow up till day 90); incidence of
moderate or severe ARDS, pneumonia, atelectases, and pneumothorax; cumulative
use and duration of sedatives, and neuromuscular blocking agents; incidence of
ICU delirium, ICU acquired weakness, ICU mortality and hospital mortality,
90-day mortality.
Background summary
Mechanical ventilation is generally seen as an invasive but safe supportive
strategy in critically ill patients with respiratory failure. However, there is
unequivocal evidence from both experimental and clinical studies that
ventilation has a strong potential to aggravate and even initiate injury to the
lungs and the respiratory muscles. Ventilation results invariably in a pattern
of ventral overstretching and dorsal collapse of lung tissue, which both play a
role in development of so*called *ventilator*induced lung injury*. Ventilation
is associated with respiratory muscle disuse and even misuse causing atrophy of
diaphragmatic myofibers, which play a role in development of so*called
*ventilator*induced diaphragm dysfunction*
The harmful effects of the traditional use of a higher tidal volume were not
recognized until 2000 when the beneficial effects of ventilation with a lower
tidal volume in patients with moderate or severe ARDS (Acute Respiratory
Distress Syndrome) were established in the landmark NHLBI ARDS Network trial.
Currently, lung protective ventilation is considered standard of care for
moderate or severe ARDS.
It is uncertain whether we should also use a lower tidal volume in patients
without moderate or severe ARDS. One meta*analysis suggested that ventilation
with a lower tidal volume benefits patients without ARDS. But there are several
arguments against use of lower tidal volume ventilation in these patients: one
argument is that a compensatory higher respiratory rate could increase sedation
needs, which could increase the incidence of ICU delirium and ICU acquired
weakness; others reasons are that this strategy could promote collapse of lung
tissue; and the use of a higher respiratory rate could increase the risk of
patient*ventilator asynchrony; more effort can induce more pendelluft and
thereby lung injury, finally, an alleged side-effect of lower tidal volume
ventilation is patient fatigue although there are no studies to support this.
All of these could offset the beneficial effects of lower tidal volume
ventilation as found in patients with moderate or severe ARDS. Thus, it is
uncertain whether ventilation with lower tidal volume should be used routinely
in all ICU patients. Consequently its use is not yet recommended in guidelines
for ventilation of patients without ARDS resulting in remarkable and unwanted
practice variation and continued use of higher tidal volumes
Study objective
The present study aims at comparing a ventilation strategy with a lower tidal
volume and a higher respiratory rate with ventilation using a higher tidal
volume and a lower respiratory rate in ICU patients without moderate or severe
ARDS.
Study design
This is a national multicenter RCT in intubated and ventilated ICU patients
without moderate or severe ARDS.
Intervention
Patients are randomly assigned in a 1:1 ratio to lower tidal volume ventilation
(4-6 ml/kg predicted body weight) or ventilation with higher tidal volumes
(8-10 ml/kg predicted body weight)
Study burden and risks
Burden and risks of the two ventilation strategies are uncertain. That's the
goal of this study. Both strategies are currently used; there is no additional
risk for patients enrolled in this study compared to standard care.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Admission to an ICU participating in this trial
- Need for intubation
- Within 1 hour of admission from the operation room or emergency room (if still intubated and ventilated), or within 1 hour of start of invasive ventilation in the ICU
- An expected duration of ventilation > 24 hours
Exclusion criteria
* Age less than 18 years
* Patients previously randomized in PReVENT
* Patients participating in other interventional trials
* Patients with moderate or severe ARDS (for Berlin consensus definition see table 1. APPENDIX I)
* Any session of ventilation > 12 hours directly preceding this ICU admission
* Patients with suspected or confirmed pregnancy
* Patients with increased and uncontrollable intracranial pressure (of *18 mmHg)
* Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD)
* Patients with asthmatic status
* Patients with premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on previous chest radiographs)
* Patients with new proven pulmonary thrombo*embolism
* Patients with any previous pneumectomy or lobectomy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02153294 |
| CCMO | NL47013.018.14 |