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)


Automatic weaning with adaptive support ventilation (ASV): effect on nurse workload and duration of spontaneous ventilation until extubation.


- candidate number1257
- NTR NumberNTR154
- ISRCTNISRCTN65935865
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR27-aug-2005
- Secondary IDsN/A 
- Public TitleAutomatic weaning with adaptive support ventilation (ASV): effect on nurse workload and duration of spontaneous ventilation until extubation.
- Scientific TitleAutomatic weaning with adaptive support ventilation (ASV): effect on nurse workload and duration of spontaneous ventilation until extubation.
- ACRONYMN/A
- hypothesisWe hypothesize that:
(1) ASV reduces the number of nurse-ventilator interactions in non-fast track cardiac surgery patients;
(2) ASV lengthens the period of spontaneous breathing, while shortening the total respiratory weaning time.
- Healt Condition(s) or Problem(s) studiedMechanical ventilation, complications, Coronary Artery Bypass Grafting (CABG)
- Inclusion criteria1. Planned uneventful cardiac surgery i.e. CABG;
2. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out.
- Exclusion criteria1. History of pulmonary disease;
2. History of pulmonary surgery;
3. Valve surgery;
4. Arrival at the IC-unit with IABP or inotropes at a more then usual rate (in ml per hour: dopamine (4), norepinephrine (4), dobutamin (4) or epinephrine [any rate]).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate1-okt-2006
- Target number of participants128
- InterventionsPatients will be either ventilated in a standard fashion (i.e., pressure controlled mechnanical ventilation or pressure support mechanical ventilation) or by ASV.
- Primary outcome1. Number of ABG analysis;
2. Number of audible alarms;
3. Number of manual changes in the ventilator settings (including (a) switches from PC to PS (only in the control group), (b) changes in minute ventilation (only in the ASV group), (c) lowering of PS-level (only in the control group);
4. Duration of period of spontaneous mechanical ventilation;
5. Duration of total period of tracheal intubation.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schultz
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Department of Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryAdaptive support ventilation (ASV) is a microprocessor-controlled mode of mechanical ventilation that maintains an operator preset minimum minute ventilation, independent of the patients activity.
ASV provides automatic selection of ventilatory settings and continuous -breath by breath- adaptation. ASV is a closed-loop control mode that may switch automatically from a pressure controlled ventilation (PCV)-like behavior to a pressure support ventilation (PSV)-like behavior, according to the patient status.
The operating principles are based on pressure-controlled synchronized intermittent mandatory ventilation (SIMV) with pressure levels and SIMV rate automatically adjusted according to measured lung mechanics at each breath.
Previous studies have tested the efficiency, safety, and adaptability of ASV. A respiratory weaning protocol based on ASV may accelerate tracheal extubation and simplify ventilatory management. Indeed, in a small study by Sulzer et al. there was a trend towards shorter duration of tracheal intubation in patients mechanically ventilated with ASV versus patients mechanically ventilated with SIMV and PSV. This non-significant reduction in intubation time was mainly caused by a shortening of time between admittance to the intensive care (IC)-unit and start of spontaneous ventilation (and not the period in which the work of breathing is progressively transferred from the ventilator to the patient).
These findings were confirmed in larger study on post-cardiac surgery patients by Petter et al. A lower number of arterial blood gas analyses (ABG) in the ASV group in the study by Sulzer et al. indicates that fewer changes of the respiratory settings were necessary, suggesting that ASV may simplify the management of respiratory weaning.
Similar findings existed in the study by Petter et al., in which ASV resulted in less manipulation of the setting and alarms. No other randomized studies have been published yet.
All patients in the above-mentioned studies were so-called 'fast-track' patients, i.e., patients that are expected to be eligible for extubation within hours after admission to the IC-unit. Investigations regarding the influence of a respiratory weaning protocol based on ASV on nurse work load and tracheal intubation time (and the period of non-spontaneous mechanical ventilation) in non-fast track patients are presently unavailable.
- Main changes (audit trail)
- RECORD20-aug-2005 - 2-sep-2009


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