search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Does standard opening of the lungs after intubation improve lung and heart function?


- candidate number15419
- NTR NumberNTR4174
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-sep-2013
- Secondary IDsThomas  Cherpanath
- Public TitleDoes standard opening of the lungs after intubation improve lung and heart function?
- Scientific TitleEARLY lung recruitment after tracheal intubation Of critically ill PatiENts
- ACRONYMEARLY OPEN
- hypothesisEarly recruitment maneuvers (RMs) after intubation result in a reduction of atelectases and subsequently improved cardiac function in comparison with standard care
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaIntubation to be performed after which trans thoracic echocardiogram and Electrical Impedance Tomography is feasible
- Exclusion criteriaRefractory circulatory instability Poor LV function (Ejection fraction < 30%) or signs of obliteration Intracranial hypertension Undrained pneumothorax or severe bullae Presence of a pacemaker, chest drains or implantable pumps
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-sep-2013
- planned closingdate31-dec-2014
- Target number of participants34
- InterventionsLung recruitment maneuvers after intubation: increasing driving pressure with steps of 10 cm H2O with an inspiratory hold of 10 seconds after each step. At a maximum of 40 cm H2O of driving pressure, PEEP is increased form 5cm H2O to 10cm H2O and the driving pressure decreased in steps of 10 cm H2O to 6-8ml tidal volume /kg lean body weight. The standard care group will receive after intubation a similar driving pressure to obtain 6-8ml tidal volume /kg lean body weight, but with 5 PEEP and without lung recruitment (only on indication if hypoxia is present at the discretion of the attending physician
- Primary outcomeRegional lung aeration assessed by Electrical Impedance Tomography
- Secondary outcomeRight ventricular function (contractile –, preload – and afterload–parameters) and overall cardiac function assessed by trans thoracic echocardiography
- Timepointst0: Within 30 minutes after intubation but just before lung recruitment
t1: 1 hour after lung recruitment
t2: 24 hours after lung recruitment
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Thomas Cherpanath
- CONTACT for SCIENTIFIC QUERIESMD Thomas Cherpanath
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryInvasive mechanical ventilation requires tracheal intubation. Intubation is facilitated by muscle paralysis, which could induce further atelectases. Atelectases compromise gas–exchange and depresses cardiac function. Early recruitment maneuvers (RMs) could resolve atelectases, but it is uncertain whether they should be applied in every intubated intensive care patient (i.e., early after intubation) or only in whom gas–exchange does not improve (i.e., only when necessary). Therefore a strategy using early recruitment maneuvers (RMs) after intubation is compared with a strategy using RMs only on indication in intensive care patients. We hypothesize that early RMs homogenize and improve lung aeration and subsequently improves right ventricular function.
- Main changes (audit trail)
- RECORD13-sep-2013 - 29-sep-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl