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

NCT ID: NCT05535543

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-06

Study Completion Date

2025-02-28

Brief Summary

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

Detailed Description

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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)

Conditions

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Acute Respiratory Distress Syndrome Ventilation Perfusion Mismatch Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Baseline slope of phase iii

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

Prone Positioning

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Olcay Dilken

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olcay Dilken, MD

Role: PRINCIPAL_INVESTIGATOR

Hamidiye Etfal Hospital

Locations

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Hamidiye Etfal Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Olcay Dilken, MD

Role: CONTACT

+905547378709

Facility Contacts

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Olcay Dilken, MD

Role: primary

+905547378709

Other Identifiers

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05072022-3605

Identifier Type: -

Identifier Source: org_study_id

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