Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode

Sponsor

Dr. Behcet Uz Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04541199

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In mechanically ventilated patients, driving pressure (ΔP) assess the strain applied to the respiratory system and is related to ICU mortality. The aim of this randomized cross-over trial was to compare ΔP selected by a closed-loop system and by physician tailored mechanical ventilation mode. Pediatric patients admitted to PICU will be enrolled if they were invasively ventilated without any detectable respiratory effort, hemodynamic instability, or significant leakages. Two 60 minute periods of ventilation determined by randomization in APV-CMV and ASV 1.1 will be compared. Settings were adjusted to reach the same minute ventilation in both modes. ΔP will be calculated as the difference between plateau pressure and total PEEP measured using end-inspiratory and end-expiratory occlusion maneuvers, respectively.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury	Device: closed loop Device: conventional	N/A

Detailed Description

In 2015, Pediatric Acute Lung Injury Consensus Conference (PALICC) determined the pediatric acute respiratory distress syndrome (PARDS) definition. PALICC recommends using patient-specific tidal volume (VT) according to disease severity. Moreover, in the absence of transpulmonary pressure measurements (PL), an inspiratory plateau pressure limit of 28 cm H2O is recommended, allowing for slightly higher plateau pressures (29-32 cm H2O) for patients with reduced chest wall compliance. In adult ARDS, Amato et al. normalized VT to the compliance(C) by using driving pressure (ΔP) and reported that ΔP was the ventilation variable that best-stratified risk. Changes in ventilator settings resulting in a decrease in ΔP were associated with increased survival. One of the most common modes used in pediatric ventilation nowadays is synchronized controlled mandatory ventilation with adaptive pressure ventilation (APV-CMV). As compared to pressure control mode (P-CMV), APV-CMV prevents low or high VT when the compliance changes by adjusting the applied pressure. Adaptive support ventilation (ASV) is closed-loop ventilation mode, which for a given minute volume set by the clinician, adapts tidal volume (VT) and respiratory rate (RR) according to the patient's respiratory mechanics.

This prospective randomized cross over study aimed to compare ΔP between physician tailored APV-CMV mode and ASV 1.1 in pediatric mechanically ventilated patients with acute respiratory failure. After the enrollment, the patients' ventilation periods will be determined by randomization using sealed opaque envelopes. The minute ventilation, fraction of inspired O2 (FiO2) and positive end-expiratory pressure (PEEP) set by the clinician before study inclusion will be kept unchanged during all study periods. Patients will be ventilated in each mode for 60 minutes. Three consecutive -inspiratory and end-expiratory occlusion will be performed at 30 and 60 min and ΔP will be calculated for each period. Arterial blood gas will be measured at the end of each period. A wash-out period of 30 min using the ventilation mode and setting before inclusion will be performed in between the two study ventilation periods. ΔP will be calculated as the difference between plateau pressure (Pplat) and total PEEP and will be averaged for each ventilation period by using the mean of the six measurements mentioned above. VT will be calculated by integration of flow measurement. Resistance will be calculated by the least-squares fitting method. The expiratory time constant (RCexp) will be derived from the volume-flow curve at 75% of the VT and corresponding flow value. Static compliance (Cstat) will be calculated as VT divided by ΔP.

The primary outcome will be ΔP. The secondary outcome will be VT, RR, Pplat, Ti, Te, Cstat, Resistance, RCexp, pH, PaO2, PaCO2 A pilot study was performed to calculate the sample size. The mean ΔP was 12.4 (±3.31) cm H2O in ASV 1.1 and 13.5 (±4.2) cm H2O in APV-CMV. By using these pilot data, and assuming the power of 0.95 and α-error of 0.05, investigators have calculated the study size as 26 patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Randomized Crossover Trial to Compare Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode in Pediatric Patients

Actual Study Start Date :

Aug 30, 2019

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional	Device: conventional RR, VT, Ti will be selected by the clinician according to the respiratory mechanics
Experimental: Closed-loop	Device: closed loop RR and VT will be selected according to the respiratory mechanics by closed loop algorithm

Arm

Intervention/Treatment

Active Comparator: Conventional

Device: conventional

RR, VT, Ti will be selected by the clinician according to the respiratory mechanics

Experimental: Closed-loop

Device: closed loop

RR and VT will be selected according to the respiratory mechanics by closed loop algorithm

Outcome Measures

Primary Outcome Measures

Driving pressure [at the end of period (60th minute)]
measured with an occlusion maneuver as the difference between plateau pressure (Pplat) and total PEEP

Secondary Outcome Measures

Tidal Volume (VT) [continuous measurement over 1 hour]
Integrated from flow measurement
Respiratory rate (RR) [continuous measurement over 1 hour]
Number of mechanically triggered breaths by the ventilator in 60 seconds
Expiratory time constant (RCexp) [continious measurement over 1 hour]
Static compliance (Cstat) [continuous measurement over 1 hour]
will be derived from volume-flow curve at 75% of the VT and corresponding flow value
Inspiratory time (Ti) [continuous measurement over 1 hour]
Time used for inspiration during each mechanically triggered breath
Expiratory time (Te) [continuous measurement over 1 hour]
Time used for expiration during each mechanically triggered breath
pH [one measurement after 1 hour]
the measure of the hydrogen ion (H-) concentration in arterial blood
PaO2 [one measurement after 1 hour]
measurement of oxygen pressure in arterial blood
PaCO2 [one measurement after 1 hour]
measurement of CO2 pressure in arterial blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All the mechanically ventilated children
between 1-months and 18-years-old
without any detectable respiratory effort
whose clinical condition are not foreseen to change within the next 3 hours

Exclusion Criteria:

septic shock
brain death diagnose,
with a leak equal or more than 40% of the current VT,
receiving extracorporeal membrane oxygenation (ECMO) or targeted temperature management (TTM),