NCT05993780

Brief Summary

ARDS management is quite complex, and mortality is high. PEEP titration is very important in mechanical ventilation. However, the most appropriate approach for PEEP titration has yet to be determined. Currently, the emphasis is on focused PEEP implementation. The present study aimed to evaluate the volume gain at different PEEP levels over the pressure-volume curve, the changes in EELV measured by the modified multiple nitrogen wash-out/wash-in technique, and the compliance with respiratory mechanics. 14 adult ARDS patients undergoing invasive mechanical ventilation were included in the study. According to the Berlin Criteria, There were two mild, seven moderates, and five severe ARDS patients. FRC and EELV with decreased PEEP titration estimates (5 cmH2O) were measured by the multiple nitrogen wash-out/washin technique. Gain and compliance values were measured over the dynamic pressure-volume curves created by the intracheal pressure sensor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

24 days

First QC Date

July 31, 2023

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Does volume gain indicate recruited lung volume?

    A dynamic compliance curve was generated during the analysis, and volume changes in this curve were determined at each PEEP level. The difference in EELV at two different PEEP levels during a descending PEEP trial was calculated as ∆EELV, and the difference between ∆EELV and the volume derived from the pressure-volume curve was calculated as "volume gain" (gain = ∆EELV - volume derived from the curve). The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.

    Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.]

Secondary Outcomes (4)

  • Static compliance correlation with volume gain.

    Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.

  • Calculation of respiratory system elastance and its correlation with volume gain.

    Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.

  • Examination of the relationship between static strain and volume gain.

    Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.

  • Investigation of the correlation between driving pressure and volume gain

    Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.

Other Outcomes (2)

  • Hemodynamic parameters of patient with ARDS were measured during different PEEP measurement.

    Measurements were taken after 10 minutes of ventilating at the PEEP level.

  • Arterial blood gas analysis

    Measurements were taken after 10 minutes of ventilating at the PEEP level.

Study Arms (1)

ARDS patient

OTHER

14 patients with ARDS were included in the study. It was planned as a single group.

Other: No drugs or biologial agents were used in our trial

Interventions

Before the measurement, a recruitment maneuver was performed for 30-40 s at a PEEP level of 20 cmH2O. At four different PEEP levels of 15, 10, 5, and 0 cmH2O, a decreasing PEEP trial was performed, and the measurement results were recorded.The measurement time at each PEEP level was chosen as 10 minutes. At the end of the measurement, static compliance was measured by applying an end-inspiratory pause. Respiratory system elastance,static strain volume gain was calculated.The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.

ARDS patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with ARDS according to the Berlin criteria
  • Berlin definition criteria: (1) presence of acute hypoxemic respiratory failure, (2) onset within 7 days of insult, or or new (within 7 days) or worsening respiratory symptoms; (3) bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules; and (4) cardiac failure not primary cause of acute respiratory failure.

You may not qualify if:

  • Patients with severe cardiovascular instability (Mean arterial pressure \<60 mmHg , Pulse \<45 or \>150), Patients with pneumothorax, Patients who have undergone pneumonectomy operation, Patients with Lung Transplantation, Patients with thoracic deformity, ARDS patients with cor pulmonale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, Department of Anesthesiology and Reanimation, MD

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 15, 2023

Study Start

August 2, 2021

Primary Completion

August 26, 2021

Study Completion

August 26, 2021

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations