Viewing Study NCT05882474



Ignite Creation Date: 2024-05-06 @ 7:04 PM
Last Modification Date: 2024-10-26 @ 2:59 PM
Study NCT ID: NCT05882474
Status: COMPLETED
Last Update Posted: 2023-05-31
First Post: 2023-05-27

Brief Title: Correlation Between PaCO2 and Respiratory Effort in Patients With COVID-19 With Extracorporeal Membrane Oxygenation
Sponsor: Peking Union Medical College Hospital
Organization: Peking Union Medical College Hospital

Study Overview

Official Title: Correlation Between Level of Partial Pressure of Carbon Dioxide and Respiratory Effort in Patients With COVID-19 Undergoing Pressure Support Ventilation With Extracorporeal Membrane Oxygenation
Status: COMPLETED
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Excessive respiratory effort may cause self-inflicted lung injury SILI and inspiratory muscle injuries stimulate desynchronization between the patient and ventilator and worsen the perfusion of extrapulmonary organs Appropriate respiratory drive and effort should be maintained during the treatment of patients with respiratory failure In contrast respiratory drive and effort are commonly increased in patients with COVID-19 pneumonia and this phenomenon may persist in critically ill patients with COVID-19 even after receiving venovenous ECMO vv-ECMO support owing to low pulmonary compliance and a high systemic inflammatory state

To reduce respiratory effort and drive ICU physicians often administer high doses of sedative drugs analgesics and muscle relaxants The prolonged use of high doses of these drugs can cause loss of the spontaneous cough reflex which in turn impairs sputum drainage and eventually worsens pulmonary consolidation and lung infections

As the partial pressure of carbon dioxide in arterial blood PaCO2 could affect the respiratory drive from the respiratory center 1 it has been shown that altering different levels of extracorporeal carbon dioxide removal in patients undergoing ECMO recovering from acute respiratory distress syndrome ARDS could alter respiratory drive We hope to find a more appropriate target for maintaining PaCO2 to control respiratory effort in patients with COVID-19 undergoing ECMO
Detailed Description: A stable environment was maintained during the study to avoid stress and abrupt stimulation

Before the start of the study sedative drugs were titrated to Richmond agitation sedation scale values of -3 to -2 an assisted breathing mode trial was conducted and support pressure level were adjusted to achieve tidal volume 6 mLkg The ECMO GF was adjusted to achieve stable baseline conditions defined as PaCO2 40 mmHg respiratory rate 25 bpm and peak airway pressure 25 cm H2O PEEP fraction of inspired oxygen pressure support ventilation PSV ECMO blood flow and dose of vasoconstrictors sedatives and analgesics remained unchanged throughout the study

The study protocol was initiated when the baseline parameters s were stable The baseline parameters including ventilation settings arterial and arterial blood gas analysis hemodynamics and indicators of respiratory effort were measured in the baseline group Then the ECMO GF was modified to 50 of the baseline and etCO2 values were monitored ECMO GF was adjusted at 5-min intervals increasing or decreasing by 05 Lmin each time until etCO2 stabilized at a level 5-10 mmHg higher than the baseline After 20 min the parameters were measured for the second time in the high-CO2 group Figure 1

The study was stopped if the heart rate HR was 140 beatsmin andor respiratory rate was 40 bpm andor systolic blood pressure 180 mmHg andor patients experienced anxiety or diaphoresis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None