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

Acute Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541199
• Other study ID #: 02018/205
• Status: Completed
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: Dr. Behcet Uz Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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),

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Intervention

Device:
• closed loop
RR and VT will be selected according to the respiratory mechanics by closed loop algorithm
• conventional
RR, VT, Ti will be selected by the clinician according to the respiratory mechanics

Locations

Country	Name	City	State
Turkey	The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital	Izmir	Turkey/izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. — View Citation

Imber DA, Thomas NJ, Yehya N. Association Between Tidal Volumes Adjusted for Ideal Body Weight and Outcomes in Pediatric Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2019 Mar;20(3):e145-e153. doi: 10.1097/PCC.0000000000001846. — View Citation

Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22. — View Citation

Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350. — View Citation

Santschi M, Jouvet P, Leclerc F, Gauvin F, Newth CJ, Carroll CL, Flori H, Tasker RC, Rimensberger PC, Randolph AG; PALIVE Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); European Society of Pediatric and Neonatal Intensive Care (ESPNIC). Acute lung injury in children: therapeutic practice and feasibility of international clinical trials. Pediatr Crit Care Med. 2010 Nov;11(6):681-9. doi: 10.1097/PCC.0b013e3181d904c0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving pressure	measured with an occlusion maneuver as the difference between plateau pressure (Pplat) and total PEEP	at the end of period (60th minute)
Secondary	Tidal Volume (VT)	Integrated from flow measurement	continuous measurement over 1 hour
Secondary	Respiratory rate (RR)	Number of mechanically triggered breaths by the ventilator in 60 seconds	continuous measurement over 1 hour
Secondary	Expiratory time constant (RCexp)		continious measurement over 1 hour
Secondary	Static compliance (Cstat)	will be derived from volume-flow curve at 75% of the VT and corresponding flow value	continuous measurement over 1 hour
Secondary	Inspiratory time (Ti)	Time used for inspiration during each mechanically triggered breath	continuous measurement over 1 hour
Secondary	Expiratory time (Te)	Time used for expiration during each mechanically triggered breath	continuous measurement over 1 hour
Secondary	pH	the measure of the hydrogen ion (H-) concentration in arterial blood	one measurement after 1 hour
Secondary	PaO2	measurement of oxygen pressure in arterial blood	one measurement after 1 hour
Secondary	PaCO2	measurement of CO2 pressure in arterial blood	one measurement after 1 hour