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Routine manual hyperinflation versus on demand manual hyperinflation in intubated and mechanically ventilated post–cardiothoracic surgery patients


- candidate number3640
- NTR NumberNTR1384
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jul-2008
- Secondary IDs 
- Public TitleRoutine manual hyperinflation versus on demand manual hyperinflation in intubated and mechanically ventilated post–cardiothoracic surgery patients
- Scientific TitleRoutine manual hyperinflation versus on demand manual hyperinflation in intubated and mechanically ventilated post–cardiothoracic surgery patients
- ACRONYMRoutine MH vs On Demand MH
- hypothesisIn patients after cardiac thoracic surgery “routine” manual hyperinflation attenuates FRC reduction after extubation.
- Healt Condition(s) or Problem(s) studiedAirways, Mechanical ventilation, Management
- Inclusion criteria1. Patients planned for coronary artery bypass grafting and/or valve surgery are recruited
2. > 18 years of age
3. written informed consent
- Exclusion criteria1. (Previous) pulmonary surgery
2. Pulmonary infection
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2008
- planned closingdate15-sep-2009
- Target number of participants100
- InterventionsTwo manual hyperinflation (MH) strategies are compared:
For the first strategy in 50 patients MH is performed routinely for the second strategy in 50 patients the MH procedure is performed only on indication.
- Primary outcome- Peripheral hemoglobin oxygen saturation (SPO2)
- Functional Residual Capacity (FRC)
- Secondary outcome- The number of MH maneuvers per patient (routinely performed as well as those on indication in the “routine” strategy group versus “on demand” in the “on demand” strategy group)
- Duration of tracheal intubation
- Length of stay in the intensive care unit
- Timepoints- preoperative
- day 1 post extubation
- day 3 post extubation
- day 5 post extubation
- Trial web siteN/A
- statusplanned
- 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)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryManual hyperinflation (MH) is a frequently performed maneuver as part of airway management in intubated and mechanically ventilated patients (1-3). MH involves disconnecting the patient from the mechanical ventilator and inflating the lungs via a manual resuscitation bag.
In case of noted sputum in the airways or when peripheral hemoglobin oxygen saturation (SpO2) falls, MH is often a first step to improve mechanical ventilation and oxygenation (so–called “on demand” MH). Some experts advocate performing MH more frequently, on a routine basis (so–called “routine” MH, e.g., every 6 hours). Although mobilization of airway secretions, prevention of sputum plugging and improved alveolar recruitment are cited as potential benefits of MH (4-6) there is no solid evidence supporting this, above all not for “routine” MH. Of note, MH could be associated with adverse events (7,8) and also could cause agitation of the patient (9).
Functional residual capacity (FRC) after cardiothoracic surgery is reduced significantly. Since MH could improve alveolar recruitment and as result the FRC, “routine” MH may benefit these patients.
- Main changes (audit trail)
- RECORD17-jul-2008 - 25-jul-2008


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