The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV in high risk patients, after cardio-thoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Intensive Care geneeskunde, postoperatieve mechanische ventilatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effectiveness of INTELLiVENT-ASV compared to conventional mechanical
ventilation:
1. Percentage of mechanical ventilation time in an optimal, acceptable or
unacceptable zone for the first three hours of postoperative mechanical
ventilation time after admission on the intensive care unit.
2. The number of successful extubations (without new intubation <48 hours)
within 24 hours, 36uur and 48 hours after surgery.
3. Mechanical ventilation time to extubation measured from the time that the
patient has a temperature> 35.5 ° C.
User-friendliness of IntelliVent-ASV compared to conventional mechanical
ventilation:
1. Based on the measurement of the number of interactions between the caregiver
and the ventilator.
2. Survey and semistructured interviews of usability and acceptance for the
caregivers.
Secondary outcome
The safety of INTELLiVENT-ASV compared to conventional mechanical ventilation:
1. Percentage of mechanical ventilation time with an oxygen saturation <85%.
2. Percentage of mechanical ventilation time in an unacceptable zone for the
first three hours of postoperative mechanical ventilation time after admission
on the intensive care unit.
Reliability of non-invasive measurements by the ventilator:
1. Comparison of the end tidal CO2 and oxygen saturation measured by the
mechanical ventilator and the arterial blood gases.
2. Percentage of mechanical ventilation time with the oxygen saturation not
measurable.
The patient friendliness of INTELLiVENT-ASV compared to conventional mechanical
ventilation:
1. The number, by the caregiver, established agitated moments of the patient.
2. The number of administrations of opiates, benzodiazepines or haloperidol.
3. RASS score: every hour until extubation or reoperation for the first 48
hours after elective surgery.
Postoperative shunting during and after mechanical ventilation:
1. The end tidal CO2 and pCO2, pO2 / FiO2 ratio in arterial blood gases; after
about 1 hour, 12 hours, 24 hours, and 0.5 till 4 hours after extubation.
2. The number of patients with pulmonary atelectasis described on the X-rays of
the thorax within 48 hours after surgery.
Background summary
Recently, Hamilton Medical has introduced the new mechanical ventilation mode
"INTELLiVENT-ASV". This is a fully closed ventilation mode that can
automatically adjust the ventilation settings based on the measured End tidal
CO2 (ETCO2) and the measured saturation (SpO2) in both passive and active
ventilated patients. Current literature has shown that this mode is safe to use
in patients admitted on the intensive care unit.
A pilot study in the Catharina Hospital Eindhoven confirmed that in
postoperative low risk patients on the intensive care unit INTELLiVENT-ASV is
safe. Compared to continuous mandatory or pressure controlled ventilation with
pressure support (conventional mechanical ventilation), INTELLiVENT-ASV is even
as effective as conventional mechanical ventilation, with a significantly
reduced number of interactions with the ventilator.
However, available research about the effectiveness of INTELLiVENT-ASV in
postoperative high risk patients is lacking. Also the knowledge about the
user-friendliness of the above modes of mechanical ventilation for the users is
lacking.
Study objective
The aim of this study is to investigate whether postoperative ventilation with
INTELLiVENT-ASV in high risk patients, after cardio-thoracic surgery, is as
effective, more user-friendly and as safe as compared to the conventional modes
of ventilation.
Study design
This is a prospective randomized study with a control group and a treatment
group of postoperative high risk patients. Through randomization will be
determined whether the participant, after surgery, will be mechanically
ventilated with INTELLiVENT-ASV and Quickwean or with conventional mechanical
ventilation.
Intervention
- The intervention group will be mechanically ventilated with INTELLiVENT-ASV
with Quickwean after surgery.
- The control group will be mechanically ventilated based on the conventional
method, consisting out of pressure or volume-controlled mechanical ventilation,
followed by pressure support.
Study burden and risks
During this study, there will be no increased risk to the patient. The
postoperative mechanical ventilation will be performed with ventilating modes
that are available on a CE approved ventilator of Hamilton. The caregiver will
be subjected to use a particular ventilating mode that was assigned to the
participating patient (INTELLiVENT-ASV with Quickwean or conventional
mechanical ventilation).
No additional invasive measurements will be done during the study.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Age above 18 years of age.
Informed consent.
Body mass index of <35 kg/m2.
Mechanical ventilation after elective cardiothorarcic surgery.
Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.
Exclusion criteria
Withdrawal of consent
The patient with a medical history of a pneumonectomy or lobectomy.
The patient wit acute respiratory distress syndrome after surgery.
The patient with a medical history of COPD Gold 3 or 4.
The patient is participating in another postoperative study performed on the intensive care.
The patient is, preoperatively determined, eligible for a shorttrack postoperative treatment program on the Post Anesthesia Care Unit.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL58975.100.16 |