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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535543
• Other study ID #: 05072022-3605
• Status: Recruiting
• Start date: September 6, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: Istanbul University-Cerrahpasa
• Contact: Olcay Dilken, MD
• Phone: +905547378709
• Email: olcaydilken[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Syndrome
• Ventilation Perfusion Mismatch

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hamidiye Etfal Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)