Correlation Between PaCO2 and Respiratory Effort in Patients With COVID-19 With Extracorporeal Membrane Oxygenation

NCT05882474 | Completed DMC

• 1 other identifier: 2023-PUMCH-A-216-2
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication; Respiratory Effort-Related Arousal

Outcome Measures

Primary Outcomes (2)

• Pressure muscle index

  During the pressure support mode, the inspiratory hold button was pressed and a physician performed an end-inspiratory occlusion maneuver. After a certain period, the patient completely stopped inspiratory effort. The difference between the end-inspiratory obstructive plateau pressure and pre-obstructive airway pressure (Paw) was used to estimate the patient's inspiratory effort and referred to as Pressure muscle index

  Not exceeding 1 hour

• airway pressure swing during occlusion

  is defined as the swing in the Paw generated by the force of the respiratory muscle under assisted ventilation when the airway is temporarily blocked (3). The expiratory airway occlusion of the ventilator was performed at random intervals during each recording. Each occlusion persisted for a single breath, as verified by the normal recovery of Paw. The maximum deviation of Paw from positive end-expiratory pressure (PEEP) during each occlusion was documented as airway pressure swing during occlusion

  Not exceeding 1 hour

Study Arms (2)

baseline group

PaCO2 35\~40mmHg

High-CO2 group

PACO2 increases by 5-10mmHg compared to baseline value and \>40mmHg

Device: PaCO2

Interventions

PaCO2 DEVICE

Level of partial pressure of carbon dioxide

High-CO2 group

Eligibility Criteria

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

Study Population

The study was conducted in the ICU of Peking Union Medical College Hospital in China. Patients with COVID-19 who had undergone ECMO and pressure support ventilation (PSV) via tracheal intubation between December 2022 and March 2023 were considered eligible for inclusion.

You may qualify if:

• Patients with COVID-19 who had undergone ECMO and pressure support ventilation (PSV) via tracheal intubation.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: May 31, 2023
• Study Start: December 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)