Effect of PEEP on Indirect Calorimetry in Critically Ill Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
Indirect calorimetry is used in intensive care to measure how much oxygen a patient consumes and how much carbon dioxide is produced. These measurements are used to estimate energy expenditure and help guide nutritional treatment. In mechanically ventilated patients, however, ventilator settings may potentially influence the accuracy of indirect calorimetry.
This study will investigate whether changes in positive end-expiratory pressure (PEEP), a routinely used ventilator setting, affect measurements obtained by indirect calorimetry in critically ill mechanically ventilated adults.
Each participant will undergo indirect calorimetry at three PEEP levels: 8, 12, and 16 cmH2O. Each PEEP level will be maintained for a stabilization period before measurements are obtained. Other ventilator settings will be kept unchanged during the measurement sequence whenever clinically feasible.
The study will compare oxygen consumption (VO2), carbon dioxide production (VCO2), respiratory quotient (RQ), and resting energy expenditure (REE) across the three PEEP levels. The aim is to determine whether clinically relevant changes in PEEP systematically influence indirect calorimetry measurements and their interpretation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Admitted to CIVA or NIVA at Sahlgrenska University Hospital.
Receiving invasive mechanical ventilation.
Expected intensive care stay longer than 72 hours.
Disqualifiers
Ongoing or planned continuous renal replacement therapy or intermittent hemodialysis (CRRT/iHD).
Extracorporeal membrane oxygenation (ECMO).
Fraction of inspired oxygen (FiO2) >0.70.
Severe renal failure or rapidly increasing creatinine where metabolic measurements may be difficult to interpret.
Trial design
Design model
Sequential
Treatments tested in this trial
Protocolized PEEP Adjustment
Other interventionPositive end-expiratory pressure (PEEP) is adjusted sequentially to 8, 12, and 16 cmH2O during a single study session. Each level is maintained until the predefined stabilization criteria are met before indirect calorimetry measurements are obtained. The sequence is performed under continuous intensive care monitoring and is discontinued if clinically relevant deterioration occurs.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Sequential PEEP LevelsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Resting Energy Expenditure Across PEEP Levels
Resting energy expenditure (REE), measured by indirect calorimetry and expressed in kcal/day, will be compared within participants across PEEP levels of 8, 12, and 16 cmH2O. The primary objective is to determine whether changes in PEEP produce systematic and clinically meaningful changes in measured REE.
Time frame
During a single study session: after approximately 20 minutes at each PEEP level (8, 12, and 16 cmH2O)Secondary outcomes
1
Oxygen Consumption Across PEEP Levels
VO₂ in mL/min compared within participants at PEEP 8, 12, and 16 cmH₂O.
Time frame
During a single study session: after approximately 20 minutes at each PEEP level (8, 12, and 16 cmH2O)2
Carbon Dioxide Production Across PEEP Levels
VCO₂ in mL/min compared within participants at the three PEEP levels.
Time frame
During a single study session: after approximately 20 minutes at each PEEP level (8, 12, and 16 cmH2O)3
Respiratory Quotient Across PEEP Levels
RQ calculated as VCO₂/VO₂ and compared within participants at the three PEEP levels.
Time frame
During a single study session: after approximately 20 minutes at each PEEP level (8, 12, and 16 cmH2O)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: