Effects of End-expiratory Positive Pressure Optimization in Intubated Patients With Healthy Lung or Acute Respiratory Distress Syndrome

NCT04503876 | Unknown

• 1 other identifier: RBHP 2019 GODET (Peep Réa)
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

PEEP titration is a recommended during invasive mechanical ventilation of ICU patients. However, little is known about the right way to conduct this titration. PEEP titration can be conducted by a stepwise increase in PEEP level, or following an ARM and a consecutive stepwise decrease in PEEP level. Those 2 methods will be explored in intubated ICU patients either with healthy lung or ARDS lungs. Physiological exploration will include end-expiratory lung volume measurements, driving pressure, compliance and electro-impedance tomography at each PEEP level.

Conditions

ICU Patients; Healthy Lung; Positive End-Expiratory Pressure; ARDS; Alveolar Recruitment Maneuver

Keywords

ICU patients; Volume-controlled ventilation; Open lung strategy; PEEP titration; Alveolar recruitment maneuver; ARDS; Healthy lungs; Intubation; Tracheotomy; End-expiratory lung volume; Electro-impedance tomography; Recruited lung volume

Outcome Measures

Primary Outcomes (1)

• Recruited lung volume at each PEEP level between the 2 strategies (incremental or decremental).

  : The main endpoint is the difference between the recruited lung volume measured by nitrogen washin-washout method at the end of each PEEP level (5th minute) with the basal value measured at the beginning of the protocol, between decremental and incremental stepwise PEEP titration

  The last minute of each Peep Step

Secondary Outcomes (12)

• Homogeneity of pulmonary aeration

  The last minute of each Peep Step

• Homogeneity of pulmonary aeration

  The last minute of each Peep Step

• Regional impedance variation

  Measurement during the last minute of each PEEP step

• Atelectrauma

  Measurement during the last minute of each PEEP step

• Lung volume variations

  Measurement during the last minute of each PEEP step

Study Arms (2)

Decremental PEEP titration following an ARM

ACTIVE COMPARATOR

PEEP will be titrated in a stepwise decremental fashion following a standardized alveolar recruitment maneuver (ARM). The ARM is a progressive increase of intra-thoracic pressure (pressure controlled mode), with a constant driving pressure of 10 cmH2O and PEEP steps (10-15-20-25-30-35 and 40 cmH2O), reaching a maximum pressure of 50 cmH2O, allowing full recruitment. PEEP steps will be conducted every 2 cmH2O (from 20 to 6 cmH2O), every 5 minutes.

Other: Decreasing PEEP setting

Incremental PEEP titration without any previous ARM

ACTIVE COMPARATOR

PEEP will be titrated in a stepwise incremental fashion without any previous alveolar recruitment maneuver (ARM). PEEP steps will be conducted every 2 cmH2O (from 6 to 20 cmH2O), every 5 minutes.

Other: Increasing PEEP setting

Interventions

Increasing PEEP setting OTHER

End expiratory lung volume and lung aeration measurements will be conducted using electrical impedance tomography and nitrogen washin-washout method. Measurements will be conducted during the last minute of each step.

Incremental PEEP titration without any previous ARM

Decreasing PEEP setting OTHER

End expiratory lung volume and lung aeration measurements will be conducted using electrical impedance tomography and nitrogen washin-washout method. Measurements will be conducted during the last minute of each step.

Decremental PEEP titration following an ARM

Eligibility Criteria

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

You may qualify if:

• Patient over 18 years of age
• ICU patients with healthy lungs or lungs with Acute Respiratory Distress Syndrome (according to Berlin criteria) under mechanically invasive controlled ventilation (intubation or tracheotomy) in the early phase of admission (\< 12h)
• Patient deeply sedated (BIS between 30 and 50) and possibly under neuromuscular blocking agents (TOF \< 2/4 at the orbicular) in case of inspiratory efforts
• Patient hemodynamically stable with an optimized volemia using a monitoring system (see protocol).
• Consent to participate
• Patient benefiting from a Social Security Insurance

You may not qualify if:

• Refusal to participate to the proposed study
• Obese patient with BMI ≥ 35 kg.cm-2
• Significant hemodynamic instability defined as \> 20% increase in catecholamine doses during the last hour, despite optimization of blood volume according to a pre-established protocol
• Contraindication to the use of the electro-impedance tomography technique
• Thoracic lesions
• Chest bandages
• Pace-maker/Implantable defibrillator
• Contraindication to the performance of an alveolar recruitment maneuver
• Major Emphysema

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

RECRUITING

Study Officials

• Thomas Godet

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Statistical analysis will be conducted by an independant statistician not involved in data collection
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional trial comparing two strategies of PEEP optimization during mechanical ventilation in two groups of ICU patients: with healthy lungs or with ARDS. The study consists of comparing pulmonary pathophysiological parameters for different PEEP levels. The first strategy implies the use of an ARM followed by a stepwise decremental PEEP titration whereas the second considers a stepwise incremental PEEP titration without any previous ARM, during controlled invasive mechanical ventilation. Each patient will receive both strategies in a random consecutive order

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: August 7, 2020
• Study Start: September 12, 2019
• Primary Completion: September 12, 2021
• Study Completion: October 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

FR (1)