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ArdsNCT05993780

An Evaluation of End-Expiratory Lung Volume and Pulmonary Mechanics With Different PEEP Levels in Mechanical Ventilation in ARDS Patients

A study testing No drugs or biologial agents were used in our trial in people with Ards, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ards
What is being tested?
No drugs or biologial agents were used in our trial
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Aug 2021to 26 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Pamukkale University

    Denizli

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

The present study was conducted in the Anesthesiology and Reanimation Intensive Care Units of Pamukkale University Hospital with the approval of Pamukkale University Non-Interventional Clinical Research Ethics Committee dated 13.07.2021 and 13th board meeting numbered 60116787-020/83538. Between August 2021 and August 2022, 17 patients were included over 18 years of age who met the Berlin criteria and were diagnosed with ARDS sedated, intubated, and mechanically ventilated. Informed written consent was obtained from the relatives.

Patients included in the study were connected to a CARESCAPE R860 (GE Healthcare) mechanical ventilator. Rocuronium bromide was administered intravenously to eliminate the spontaneous respiratory effort and opioids for sedation. Tidal volume was adjusted as 6 ml/kg according to the estimated body weight; the respiratory rate was adjusted to ensure normocarbia in blood gas analysis; FiO2 was adjusted as PaO2 55 to 80 mmHg; end-inspiratory pause was adjusted to 20%, and inspiratory/expiratory ratio was adjusted as 1:2.

The ECOV-X (GE Healthcare) module was attached to the ventilator for gas measurements and allowed to warm up. A spirometer kit was inserted between the Y-piece in the ventilator circuit and the bacterial/viral filter with heat and moisture-retaining properties. An intratracheal pressure sensor was inserted to measure pressure levels independent of circuit and tube resistance and to evaluate them on the SpiroDynamics (GE Healthcare) application. EELV was measured with the ECOV-X (GE Healthcare) module using a modified NMBW technique with the change in FiO2. EELV was calculated using VO2 (oxygen consumption) and VCO2 (carbon dioxide production). After all the connections were completed, the VO2 and VCO2 values of the patients were measured. The PEEP titration procedure called Lung INview (GE Healthcare) was initiated in patients whose values stabilized within 30 min. 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.

For the same PEEP levels, the shunt fraction decreases when a decreasing PEEP maneuver is used instead of an increasing PEEP maneuver. This suggests that the relationship between optimal PEEP and maximum compliance may be more accurate. Therefore, decreasing PEEP trials was preferred as the study protocol.

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. Tidal volume, peak, and driving pressure were recorded at each step. Respiratory system elastance was calculated using the equation by Henderson et al.(respiratory system elastance = driving pressure/tidal volume). The static strain was calculated using the equation using the tidal volume at the relevant PEEP value (static strain =VPEEP/FRC). The pressure-volume curve generated by the intratracheal pressure sensor at each PEEP level was evaluated using the SpiroDynamics application. 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. The efficiency of the volume gains concept as an indicator of the volume gained by alveolar recruitment and its role in personalized PEEP titration was evaluated.

Conditions
Ards
Being tested
No drugs or biologial agents were used in our trial
Medical subject headings
Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No drugs or biologial agents were used in our trialOther

    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.

Study groups in NCT05993780
Study groupRoleWhat they receive
ARDS patientOther14 patients with ARDS were included in the study. It was planned as a single group.
Receives: Other: No drugs or biologial agents were used in our trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)
  1. Static compliance correlation with volume gain.

    After measuring the volume gain, its correlation with static compliance was examined. 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

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

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

    Respiratory system elastance was calculated using the equation (respiratory system elastance = driving pressure/tidal volume).

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

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

    Static strain; calculated by the ratio of tidal volume to FRC at the relevant PEEP level.

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

  4. Investigation of the correlation between driving pressure and volume gain

    During the measurements, volume gain and driving pressure at different PEEP levels were recorded and their correlations were examined.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start2 Aug 2021
  3. Primary completion26 Aug 2021
  4. Study completion26 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993780
Sponsor's protocol ID
PamukkaleUSyuksel-001
Status last verified
Aug 2023
First submitted
31 Jul 2023
Last updated
15 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing No drugs or biologial agents were used in our trial in people with Ards, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Does volume gain indicate recruited lung volume? (time frame: Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.

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