The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With ARDS Due to Pneumonia

NCT06477861 | Recruiting DMC

• 1 other identifier: MD.11.12.2023
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

the role of elastic power in the prediction of severity and mortality in adults with ARDS secondary to pneumonia

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 28 day mortality

  \- survivors are defined as patients who are discharged from ICU or survive beyond 28 days

  28 days

Secondary Outcomes (1)

• elastic power normalized to compliance

  28 days

Study Arms (2)

mild to moderate ARDS

100 =\< PO2/FiO2 ratio \< 300

Other: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity

severe ARDS

100 \< PO2/FiO2 ratio

Other: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity

Interventions

calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity OTHER

calculation of variables of the elastic power of the lung from the lung pressures on the ventilator : Elastic power = 0.098 \* tidal volume \* respiratory rate \* 1/2(PEEP+Pplat)

mild to moderate ARDS; severe ARDS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It's the population from which sample size will be non randomly selected. The study will be on ARDS patients who will be admitted to ICU of Benha University hospitals . a) Sample size : The sample size was calculated using G\*power software based on a previous study by Xie , who investigated the elastic power as a predictor of ARDS severity. They reported a large effect size of elastic power between mild to moderate and moderate to severe ARDS patients. The minimum sample size needed to detect a large effect size (d = 0.8) between such groups is 70 patients (at least 20 with mild to moderate disease and 50 with severe disease). Alpha and power levels were adjusted at 0.05 and 0.8, respectively

You may qualify if:

• Age from 18 to 65 years (male or female). Patients fulfilling criteria of ARDS as per Berline definition who will be admitted to ICU , intubated and MV more than 48 hours will be included in this study.
• Fulfillment of Criteria of readiness for ARDS as per Berline definition :
• an acute onset (\<1 week of a known clinical insult or new or worsening respiratory symptoms),
• respiratory failure not primarily due to hydrostatic edema,
• bilateral opacities on a chest radiograph (not fully explained by effusions, lobar or lung collapse, or nodules), and
• \<300 mmHg of the ratio of arterial partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2) with 5 cm H2O of positive end-expiratory pressure (PEEP) or continuous positive airway pressure. To facilitate the estimation of the ARDS prognosis, the Berline definition classifies the severity of ARDS into 3 categories: mild (200 mmHg \< PaO2/FiO2 \< 300 mmHg), moderate (100 mm Hg \< PaO2/FiO2 \<200 mmHg), and severe (PaO2/FiO2 \< 100 mmHg).

You may not qualify if:

• Non intubated ICU admissions
• Non-invasive ventilated patients.
• Age less than 18 years or more than 65 years of age
• Open chest wall trauma.
• Patient requiring Extra Corporal Membrane Oxygenator
• Patients with increased intrabdominal pressure interfering with mechanical ventilator parameters measurements

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University Hospital

Banhā, Al Qalubeyah, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Samar R Mohammed

  lecturer of anaesthesia and critical care

  STUDY DIRECTOR

Central Study Contacts

Ahmed H Awad, MsC.ICU

CONTACT

+971561707026; ahmedhossam79@gmail.com

Samar R Mohamed

CONTACT

01287793991

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 27, 2024
• Study Start: January 24, 2024
• Primary Completion: September 24, 2024
• Study Completion: October 24, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

EG (1)