Pv-aCO₂ Gap-Guided Resuscitation in Adult Polytrauma Patients: A Prospective Randomized Controlled Trial

Official title

Evaluation of Effect of Pv-aCO2-Gap on Clinical Outcomes With Standard Resuscitation End-points in Adult Poly-trauma Patients Admitted to the ICU --- Prospective Randomized Control Trial

Overview

dult patients with multiple traumatic injuries admitted to the ICU from the operating room, emergency department, or hospital wards who meet the study criteria will be included after obtaining informed consent from the patient or their legal guardian. Participants will be randomly divided into two groups: one group will receive treatment guided by the difference between carbon dioxide levels in venous and arterial blood, while the other group will receive treatment based on standard resuscitation parameters commonly used in critical care. As part of routine monitoring, all patients will have a central venous catheter and an arterial line inserted to measure blood parameters. Blood samples from both lines will be taken shortly after ICU admission and at regular intervals during the first three days. These samples will be analyzed using a bedside blood gas machine, and the results will be compared between the two groups to determine whether monitoring the difference in carbon dioxide levels between venous and arterial blood improves patient outcomes compared with standard care.

Detailed description

All polytrauma patients admitted to the ICU from the operating theater, emergency department, or hospital wards who fulfill the inclusion criteria will be enrolled in the study after obtaining written informed consent from the patients or their legal representatives. Participants will be randomized in a 1:1 ratio using a computer-generated method into two groups: an intervention group managed with a Pv-aCO₂ gap-targeted approach and a control group managed according to standard resuscitation end-points. As part of routine hemodynamic monitoring in critical care, a central venous catheter (two- or three-lumen catheter-Arrow) and an arterial catheter (Arterial Leader Cath-Vygon or Teleflex) will be inserted in all participants before or immediately after ICU admission. After insertion, the position of the central venous catheter tip at the junction of the superior vena cava and right atrium will be confirmed by chest X-ray. Arterial and venous blood samples for blood gas analysis (ABGA and VBGA) will be obtained in the ICU using a point-of-care gas analyzer (ABL800 FLEX®, Radiometer) within 1 hour of ICU admission and subsequently at 6, 12, 24, 48, and 72 hours. The time interval between arterial and venous blood sampling will be kept under 5 minutes to minimize bias, and the measurements obtained at different time points will be compared with standard resuscitation end-points.

Interventions

• Diagnostic test Veno-arterial Carbondioxide gap
  Arterial and central venous blood samples will be obtained for blood gas analysis using a point-of-care blood gas analyzer (ABL800 FLEX®, Radiometer). Sampling will be performed within 1 hour of ICU admission and subsequently at 6, 12, 24, 48, and 72 hours during the ICU stay. The measurements will be used to assess arterial and venous blood gas parameters for monitoring and guiding patient management.
• Diagnostic test Conventional resuscitation end points
  Patients in this group will be managed using standard resuscitation parameters, including monitoring of arterial base deficit, arterial pH, serum lactate levels, and bicarbonate levels. These parameters will be measured through arterial blood gas analysis within 1 hour of admission to the ICU and subsequently at 6, 12, 24, 48, and 72 hours during the ICU stay, and will be used to guide ongoing resuscitation and clinical management.

Primary outcome measures

• Length of mechanical ventilation [Time frame: This will be the number of days of ventilatory support once patient is admitted to ICU]

Secondary outcome measures (3)

• ICU stay [Time frame: This will the total length of ICU stay measured in number of days]
• ICU Mortality [Time frame: This will be the death occurring during ICU stay]
• qSOFA score [Time frame: This will be measured at time of admission in ICU then at 48h and 72h following admission]

Eligibility criteria

Inclusion criteria

• Either Gender
• Poly-trauma patients

○ Both penetrating and blunt trauma

• Both surgical and non-surgical
• Shock States

Exclusion criteria

• Any Chest trauma
• Patients with Obstructive and restrictive lung disease
• Obstructive sleep apnea
• Septic shock
• Pregnant patients
• Patients who will require readmission within 48 h after step-down from the ICU.
• Patients who will need extra-corporeal membrane oxygenation support

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Department of Anesthesia, Pakistan Institute of Medical Sciences — Islamabad

Publications

• Doppmann P, Meuli L, Sollid SJM, Filipovic M, Knapp J, Exadaktylos A, Albrecht R, Pietsch U. End-tidal to arterial carbon dioxide gradient is associated with increased mortality in patients with traumatic brain injury: a retrospective observational study. Sci Rep. 2021 May 17;11(1):10391. doi: 10.1038/s41598-021-89913-x. PMID 34001982

Identifiers

NCT: NCT07480655 · F5.2/2024(ERRC)/PIMS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗