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

Pakistan Institute of Medical Sciences

Status and phase: Enrolling; Phase 4

Conditions: Resuscitation, Trauma Patients; Polytrauma

Treatments: Diagnostic Test: Conventional resuscitation end points; Diagnostic Test: Veno-arterial Carbondioxide gap

Study type: Interventional

Funder types: Other

Identifiers

NCT07480655

F5.2/2024(ERRC)/PIMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Carbondioxide gap group

Experimental group

Treatment:

Diagnostic Test: Veno-arterial Carbondioxide gap

Conventional resuscitation group

Active Comparator group

Treatment:

Diagnostic Test: Conventional resuscitation end points