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

Recruiting

• Conditions: Ventilation Perfusion Mismatch; Respiratory Failure; Acute Respiratory Distress Syndrome
• Interventions: Procedure: Prone Positioning

• Registration Number: NCT05535543
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

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 Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-01-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Baseline slope of phase iii	Prone Positioning	Severe ARDS patients who are intubated and mechanically ventilated and will undergo prone positioning

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hamidiye Etfal Hospital; 🇹🇷 Istanbul, Turkey