Influence of Respiratory Mechanics on Brain-specific Monitoring in Brain-injured Patients

NCT04013698 | Withdrawn DMC

• 1 other identifier: ABIVENT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Increase in intracranial pressure (ICP) could be associated with increase in positive end-expiratory pressure (PEEP) level. Data are however disparate and interactions between ventilation with high PEEP and intracranial circulation are still debated. Individual patient's chest wall elastance could have a key role in determining the effects of PEEP on ICP, since it dictates which proportion of the applied PEEP is transmitted to the pleural space, thus increasing central venous pressure (CVP) and reducing cerebral venous return. Measurement of esophageal pressure with a dedicated probe allows partitioning of respiratory system elastance into its lung and chest wall components, thus permitting to study this phenomenon. Multimodal intracranial monitoring permits to study the effects of PEEP on more advanced brain-specific indices such as brain tissue oxygen (PtiO2), cerebral microdialysis data, transcranial doppler ultrasound-derived flow measurements and automated pupillometry, besides ICP. This study aims to test the association between the ratio of chest wall to respiratory system elastance and PEEP-induced variations in ICP and brain-specific multimodal monitoring indices. This study will evaluate the relative role of other selected measures of respiratory mechanics, hemodynamic variables and intracranial compliance, in order to establish the role of individual respiratory mechanics in the interplay of physiological factors affecting the effects of positive pressure ventilation on the brain. Patients will undergo two periods of ventilation at two different levels of PEEP (5 and 15 cmH2O) in a randomized cross-over order. At the end of each period, cardiorespiratory clinical data, ICP and other advanced multimodal neuromonitoring data (brain tissue oxygen tension, cerebral microdyalisis analytes, transcranial doppler ultrasound and automated infrared pupillometry data) will be collected. Systematic respiratory mechanics assessment (including calculation of chest wall and lung elastances and estimation of the amount of recruitment versus overdistension due to PEEP by means of a single-breath derecruitment trial), echocardiography and arterial blood gas analysis will be performed.

Conditions

Brain Injuries

Keywords

ventilation; brain injuries; PEEP; esophageal pressure

Outcome Measures

Primary Outcomes (1)

• Correlation between Ers/Ecw and change in ICP between the two PEEP levels

  Respiratory mechanics; intracranial pressure monitoring Ers/Ecw = chest wall to respiratory system elastances ratio; ICP = intracranial pressure

  Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes

Secondary Outcomes (19)

• Correlation between Ecw/Ers and the following neuromonitoring indices at the two PEEP levels: PtiO2, LPR, NPI; MFV, DFV and PI.

  Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes

• Effect of the two different levels of PEEP on NPI.

  Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes

• Effect of the two different levels of PEEP on the following transcranial doppler ultrasound variables: MFV, DFV and PI.

  Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes

• Effect of the two different levels of PEEP on LPR.

  Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes

• Effect of the two different levels of PEEP on PtiO2.

  Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes

Study Arms (2)

PEEP level 5 cmH2O to 15 cmH2O

EXPERIMENTAL

Other: PEEP level 5 cmH2O; Other: PEEP level 15 cmH2O

PEEP level 15 cmH2O to 5 cmH2O

EXPERIMENTAL

Other: PEEP level 5 cmH2O; Other: PEEP level 15 cmH2O

Interventions

PEEP level 5 cmH2O OTHER

PEEP level set for 45 minutes

PEEP level 15 cmH2O to 5 cmH2O; PEEP level 5 cmH2O to 15 cmH2O

PEEP level 15 cmH2O OTHER

PEEP level set for 45 minutes

PEEP level 15 cmH2O to 5 cmH2O; PEEP level 5 cmH2O to 15 cmH2O

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute brain injury of any etiology requiring multimodal brain monitoring (intraparenchymal intracranial pressure, brain-tissue oxygen tension and cerebral microdialysis)
• Controlled mechanical ventilation via endotracheal tube
• Patient needing deep sedation

You may not qualify if:

• pregnancy
• contraindications to nasogastric probe placement: basilar skull or significant naso-facial fractures, significant esophageal or gastric trauma or bleeding, previous esophageal surgery, significant bleeding diathesis (spontaneous aPTT \> 60 sec, PT \< 40%, INR \> 1.8, platelets \< 50000/mm3), known esophageal or gastric varices
• decompressive craniectomy
• intracranial pressure monitoring method other than intraparenchymal (e.g. connected to external ventricular drain)
• severe relevant physiological instability contraindicating an increase in PEEP: severe baseline intracranial pressure elevation (\> 20 mmHg), severe hemodynamic instability (defined as norepinephrine requirements \> 0.5 μg/kg/min or cardiogenic shock, defined as any use of dobutamine)
• conditions that interfere with accurate measurements of respiratory mechanics: bronchopleural fistula, pneumothorax.
• Withhold of life-sustaining therapy for medical reasons

Sponsors & Collaborators

• Piquilloud Imboden Lise: lead

Study Sites (1)

Lausanne University Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Piquilloud, MER&PD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Patients included will receive volume assist-control ventilation with PEEP set at 5 cmH2O and 15 cmH2O in a randomized order (crossover design). Each setting will be applied during 45 minutes.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 10, 2019
• Study Start: August 1, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: June 11, 2021

Record last verified: 2020-11

Locations

CH (1)