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

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05535543

Collaborator

(none)

Enrollment

Location

9.8

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Ventilation Perfusion Mismatch Respiratory Failure	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.

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)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 6, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in phase iii slope of the volumetric capnograph [16 to 24 hours (according to time spent in the prone position)]
phase iii slope is associated with the ventilation homogeneity
correlation of the phase iii slope with the recruitment to inflation ratio [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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