Acute Respiratory Failure With Hypoxia Clinical Trial
Official title:
Application of PEEP in Patients With Acute Respiratory Failure Caused by Lung Injury: Assessment of Clinical Practice
NCT number | NCT04912960 |
Other study ID # | 170090 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 10, 2021 |
Est. completion date | June 30, 2024 |
Positive end-expiratory pressure (PEEP) has become an essential component of the care of critically ill patients who require ventilatory support. In 1975, several investigators published the effects of PEEP in 15 mechanically ventilated patients with acute respiratory failure (ARF) supported by mechanical ventilation. FiO2 ranged between 21% to 75% and the tidal volume between 13 to 15 mL/kg. PEEP was increased in 3 cmH2O steps until cardiac output fell. The aim was to identify the "optimum" PEEP level. "Best" PEEP was associated simultaneously with the best static compliance of the respiratory system, the greatest oxygen transport, and the lowest dead space fraction. That study established the basis for the use of PEEP in patients with ARF worldwide. Although currently patients with ARF are ventilated with much lower tidal volumes, that study has never been validated. It is unknow whether their findings are currently valid, generalizable, and reproducible.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Intubated patients requiring MV for >24 h - Age >18 years - Acute hypoxemic respiratory failure, defined as a PaO2/FiO2 <300 with an FiO2 =0.3 and PEEP=5 cmH2O. - ARF caused by pulmonary insults. Exclusion Criteria: - ARF from non-pulmonary origin. - Contraindications from high PEEP (severe head trauma or severe chest trauma). - Patients that cannot maintained supine position. - Uncorrected hypovolemia - Hemodynamic instability |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic | Barcelona | |
Spain | Hospital Universitario Dr. Negrin | Las Palmas De Gran Canaria | Las Palmas |
Spain | Hospital Universitario La Princesa | Madrid |
Lead Sponsor | Collaborator |
---|---|
Jesus Villar |
Spain,
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. — View Citation
Suter PM, Fairley B, Isenberg MD. Optimum end-expiratory airway pressure in patients with acute pulmonary failure. N Engl J Med. 1975 Feb 6;292(6):284-9. doi: 10.1056/NEJM197502062920604. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | static compliance of the respiratory system | ratio of tidal volume to pressure gradiente of the respiratory system | at study enrollment | |
Primary | oxygen transport | Cardiac output multiply by oxygen content in arterial blood | at study enrollment | |
Primary | dead space fraction | ratio of dead space to tidal volume | at study enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04681040 -
Risk Stratification of COVID-19 Using Urine Biomarkers
|
||
Active, not recruiting |
NCT04079829 -
Postoperative Respiratory Abnormalities
|
||
Completed |
NCT03021824 -
Severe ARDS: Generating Evidence
|
||
Active, not recruiting |
NCT02654327 -
pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
|
Phase 3 | |
Completed |
NCT04693403 -
Adult Respiratory Failure Intervention Study Africa
|
N/A | |
Recruiting |
NCT04368975 -
ARDS Caused by COVID-19
|
||
Recruiting |
NCT02050217 -
NAVA Helmet in Pediatric Respiratory Failure
|
Phase 3 | |
Recruiting |
NCT03311087 -
Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure
|
||
Recruiting |
NCT03467854 -
PK of Piperacillin/Tazobactam in Adults Undergoing ECMO
|
||
Completed |
NCT04664322 -
High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure
|
||
Completed |
NCT02167542 -
Positive Pressure During Bronchoscopy
|
N/A | |
Completed |
NCT03326830 -
Prehospital High-Flow Nasal Oxygen Therapy
|
N/A | |
Terminated |
NCT01937884 -
Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
|
Phase 2 |