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NCT Number: NCT05535543

Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome

This study evaluates the effects of prone positioning on homogenization of ventilation.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Ventilation Perfusion Mismatch

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamidiye Etfal Hospital

Istanbul, 34000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Olcay Dilken, MD

CONTACT

[email protected]

+905547378709

About this study

After initiation of mechanical ventilation and assessing the eligibility of the patient, informed consent will be taken from the closest kin. If eligible, following steps will be performed which are part of standard ARDS patient care.

  • Low-flow Pressure Volume curve and assessment of airway opening pressure
  • Calculation of recruitment to inflation ratio
  • Optimizing Positive End-Expiratory Pressure

Afterwards, phase III slope of the patient will be recorded at four timepoints:

Supine 1 (immediately before turning to prone position) Prone 1 (immediately after prone position) Prone 2 (at the end of the 16-24 hour prone cycle) Supine 2 (immediately after turning to supine position)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ARDS criteria met
  • intubated and mechanically ventilated as a result of respiratory failure
  • PaO2/FiO2 <200

Exclusion criteria

  • age older than 18
  • Chronic pulmonary disease, pneumothoraces, intraabdominal hypertension (> 12 mmHg), pregnancy, not expected to survive >24 hours, hemodynamic instability

Treatment and study plan

Prone positioning

Procedure

Patients will be turned to prone position and they will be left in prone position for a duration of at least 16 hours to a maximum of 24 hours. This duration is recommended by the ARDS guidelines.

Primary outcomes

  1. Change from baseline in phase iii slope of the volumetric capnograph

    Time frame: 16 to 24 hours (according to time spent in the prone position)

    phase iii slope is associated with the ventilation homogeneity

  2. correlation of the phase iii slope with the recruitment to inflation ratio

    Time frame: 16 to 24 hours (according to time spent in the prone position)

    recruitment to inflation ratio is a simple bedside tool that indicates a higher possible recruitable lung with higher applied Positive End-Expiratory Pressure

Secondary outcomes

  1. correlation of the phase iii slope with the Partial pressure of the arterial oxygen/ Fraction of inspired O2 concentration (PaO2/FiO2) ratio

    Time frame: 16 to 24 hours (according to time spent in the prone position)

    PaO2/FiO2 is markedly reduced in ARDS patients as a consequence of aeration loss

Study contacts

Contact information is provided by the study sponsor or research team.

Olcay Dilken, MD

CONTACT

[email protected]

+905547378709

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Assessment of the Effects of Prone Positioning Among ARDS Patients on Ventilation Homogenization by the Phase Iii Slope of the Volumetric Capnography

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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