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

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

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

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Acute Respiratory Distress Syndrome; Ventilation Perfusion Mismatch
• Intervention / Treatment: Procedure: Prone Positioning

Detailed Description

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.

1. Low-flow Pressure Volume curve and assessment of airway opening pressure
2. Calculation of recruitment to inflation ratio
3. 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)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Olcay Dilken, MD; Phone Number: +905547378709; Email: olcaydilken@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Recruiting
    • Hamidiye Etfal Hospital
    • Contact: Olcay Dilken, MD; Phone Number: +905547378709; Email: olcaydilken@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult mixed critical care patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Baseline slope of phase iii; Severe ARDS patients who are intubated and mechanically ventilated and will undergo prone positioning	Procedure: Prone Positioning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in phase iii slope of the volumetric capnograph	phase iii slope is associated with the ventilation homogeneity	16 to 24 hours (according to time spent in the prone position)
correlation of the phase iii slope with the recruitment to inflation ratio	recruitment to inflation ratio is a simple bedside tool that indicates a higher possible recruitable lung with higher applied Positive End-Expiratory Pressure	16 to 24 hours (according to time spent in the prone position)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation of the phase iii slope with the Partial pressure of the arterial oxygen/ Fraction of inspired O2 concentration (PaO2/FiO2) ratio	PaO2/FiO2 is markedly reduced in ARDS patients as a consequence of aeration loss	16 to 24 hours (according to time spent in the prone position)

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Olcay Dilken, MD, Hamidiye Etfal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; prone; Volumetric Capnography; phase iii slope
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 05072022-3605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No