The full closed loop ventilation mode Intellivent-ASV: user-friendly and effective mechanical ventilation in high risk postoperative patients on the intensive care unit.

Intellivent-ASV: effective and user-friendly postoperative ventilation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27583

Enrollment

400

Registered

2016-08-16

Start date

2016-10-30

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellivent-ASV ventilation mode Fully closed loop ventilation Conventional ventilation mode Postoperative ventilation

Interventions

- The intervention group will be mechanically ventilated with IntelliVent-ASV after surgery. - The control group will be mechanically ventilated based on the conventional method, consisting out of pr

Eligibility

Inclusion criteria

Inclusion criteria: - Age above 18 years of age. - Informed consent. - Body mass index of <35 kg/m2. - Mechanical ventilation after elective surgery. - Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.

Exclusion criteria

Exclusion criteria: - 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 an other postoperative study performed on the intensive care.

Design outcomes

Primary

Measure	Time frame
The effectiveness of IntelliVent-ASV compared to conventional mechanical ventilation: 1. Percentage of mechanical ventilation time in an optimal, acceptable or unacceptable zone. 2. The number of successful extubations (without new intubation 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 of usability and acceptance for the caregivers.	—

Measure

Time frame

The effectiveness of IntelliVent-ASV compared to conventional mechanical ventilation: 1. Percentage of mechanical ventilation time in an optimal, acceptable or unacceptable zone. 2. The number of successful extubations (without new intubation 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 of usability and acceptance for the caregivers.

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Secondary

Measure	Time frame
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. 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. 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.	—

Measure

Time frame

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. 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. 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.

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Contacts

Public ContactAJR De Bie Dekker

Department Intensive Care Unit

ashley.d.bie@catharinaziekenhuis.nl0031-40 239 95 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)