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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05882474
Collaborator
(none)
10
1
3.9
2.6

Study Details

Study Description

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 mL/kg. 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 0.5 L/min 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 beats/min and/or respiratory rate was

40 bpm and/or systolic blood pressure > 180 mmHg and/or patients experienced anxiety or diaphoresis.

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date :
Dec 1, 2022
Actual Primary Completion Date :
Mar 30, 2023
Actual Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
baseline group

PaCO2 35~40mmHg

High-CO2 group

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

Device: PaCO2
Level of partial pressure of carbon dioxide

Outcome Measures

Primary Outcome Measures

  1. Pressure muscle index [Not exceeding 1 hour]

    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

  2. airway pressure swing during occlusion [Not exceeding 1 hour]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05882474
Other Study ID Numbers:
  • 2023-PUMCH-A-216-2
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2023