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

NCT05535543 | Recruiting

• 1 other identifier: 05072022-3605
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome; Ventilation Perfusion Mismatch; Respiratory Failure

Keywords

Acute Respiratory Distress Syndrome; Volumetric Capnography; phase iii slope; prone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

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

Study Arms (1)

Baseline slope of phase iii

Severe ARDS patients who are intubated and mechanically ventilated and will undergo prone positioning

Procedure: Prone Positioning

Interventions

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.

Baseline slope of phase iii

Eligibility Criteria

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

Study Population

Adult mixed critical care patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Hamidiye Etfal Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Olcay Dilken, MD

  Hamidiye Etfal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olcay Dilken, MD

CONTACT

+905547378709; olcaydilken@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 6, 2022
• Primary Completion: January 30, 2025
• Study Completion: February 28, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)