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

NCT04541199 | Completed

• 1 other identifier: 02018/205
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury

Keywords

Driving pressure,; Pediatric acute respiratory distress syndrome (PARDS),; Acute lung injury (ALI),; Closed loop ventilation; Pediatric intnsive care unit (PICU)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Tidal Volume (VT)

  continuous measurement over 1 hour

• Respiratory rate (RR)

  continuous measurement over 1 hour

• Expiratory time constant (RCexp)

  continious measurement over 1 hour

• Static compliance (Cstat)

  continuous measurement over 1 hour

• Inspiratory time (Ti)

  continuous measurement over 1 hour

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Device: conventional

Closed-loop

EXPERIMENTAL

Device: closed loop

Interventions

closed loop DEVICE

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

Closed-loop

conventional DEVICE

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

Conventional

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital

Izmir, Turkey/izmir, 35200, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 20228688 BACKGROUND

• 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.

  PMID: 25647235 BACKGROUND

• 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.

  PMID: 28936698 BACKGROUND

• 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.

  PMID: 25693014 BACKGROUND

• 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.

  PMID: 30640889 BACKGROUND

• Ceylan G, Topal S, Atakul G, Colak M, Soydan E, Sandal O, Sari F, Agin H. Randomized crossover trial to compare driving pressures in a closed-loop and a conventional mechanical ventilation mode in pediatric patients. Pediatr Pulmonol. 2021 Sep;56(9):3035-3043. doi: 10.1002/ppul.25561. Epub 2021 Jul 22.

  PMID: 34293255 DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor, Head of pediatric intensive care unit (PICU)

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 9, 2020
• Study Start: August 30, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TU (1)