“The Effect of Body Positioning on Intra-Abdominal Pressure Measurement: A Multicenter Analysis”
STUDY SITE NUMBER: ______PATIENT NUMBER: ______
Case Report Form Example
As developed by the
Clinical Trials Workgroup
of the
World Society of the Abdominal Compartment Syndrome
Note.
- This document serves as an example of how to create a case report form.
- The data collection sheets should be changed and adapted as needed to serve the needs of your proposed study.
PATIENT NAME: ______
MEDICAL RECORD NUMBER: ______
DATA COLLECTION FORMS
INSTRUCTIONS
- These data collection sheets should be used to record the data points for the study.
- Enter the study site number assigned to your institution on the top of each data collection sheet.
- Enter the number of each patient enrolled at your site in sequential order. For example, the first patient should be “001”, the second “002”, the third “003”, etc…
- Enter the patient’s name and medical record number to assist in data collection at your study site.
- Once data collection is complete, enter the study data into the online database on the WSACS website ().
- Following data entry into the website, please keep a copy of all data collection sheets for 5 years.
PATIENT SCREENING
Please indicate that the following inclusion criteria have been met:
Yes NoInformed consent signed (please attach a copy of the consent to the
data collection sheets) OR waiver of informed consent granted
Yes NoPatient is at least 18 years of age
Yes NoPatient has at least one of the following IAH risk factors
(check all that apply):
Acidosis (pH below 7.2)
Hypothermia (core temperature below 33°C)
Polytransfusion (> 10 units of packed red cells / 24 hours)
Coagulopathy (platelet count below 55000/mm3 OR an activated partial thromboplastin time (APTT) more than 2 times normal OR a prothrombin time (PTT) below 50% OR an international standardised ratio (INR) more than 1.5)
Sepsis (as defined by the American - European Consensus Conference definitions)
Bacteraemia
Liver dysfunction with ascites
Mechanical ventilation
Use of positive end expiratory pressure (PEEP) or the presence of auto-PEEP
Pneumonia
Abdominal surgery, especially with tight abdominal closures
Massive fluid resuscitation (> 5 liters of colloid or crystalloid / 24 hours)
Gastroparesis / gastric distention / Ileus
Haemoperitoneum
Pneumoperitoneum
Yes NoThe patient is sedated and on mechanical ventilation
Patient is excluded from the study because (check if applies):
There is not a commitment on the part of the medical team, the subject, or the subject’s family to full aggressive support, including operative intervention if indicated.
Patient is unable to tolerate changes in bed position due to spinal precautions, intracranial hypertension, hemodynamic instability, or any other reason.
PATIENT DEMOGRAPHICS
AgeGender / Male Female
Weight (kg)
Height (cm)
ICU admission diagnosis
(please describe)
BASELINE ASSESSMENT
Calculate the following scores using the attached worksheets and enter values in the boxes below.
APACHE-II scoreSOFA score
SAPS-2 score
MEASUREMENT SET #1
Date: ______Time: ______
RASS score: ______
Positive end-expiratory pressure: ______(cm H2O)
Is the patient’s abdominal fascia closed? (please check) Yes No
Intra-abdominal pressure (IAP) measurements:
Body position Zero reference point / Supine / 15º HOB elevation / 30º HOB elevation
Symphysis pubis
Iliac crest
Phlebostatic axis
Mean arterial pressure (MAP)
Peak inspiratory pressure
Mean airway pressure
Comments: ______
______
______
MEASUREMENT SET #2
Date: ______Time: ______
RASS score: ______
Positive end-expiratory pressure: ______(cm H2O)
Is the patient’s abdominal fascia closed? (please check) Yes No
Intra-abdominal pressure (IAP) measurements:
Body position Zero reference point / 15º HOB elevation / 30º HOB elevation / Supine
Symphysis pubis
Iliac crest
Phlebostatic axis
Mean arterial pressure (MAP)
Peak inspiratory pressure
Mean airway pressure
Comments: ______
______
______
MEASUREMENT SET #3
Date: ______Time: ______
RASS score: ______
Positive end-expiratory pressure: ______(cm H2O)
Is the patient’s abdominal fascia closed? (please check) Yes No
Intra-abdominal pressure (IAP) measurements:
Body position Zero reference point / 30º HOB elevation / Supine / 15º HOB elevation
Symphysis pubis
Iliac crest
Phlebostatic axis
Mean arterial pressure (MAP)
Peak inspiratory pressure
Mean airway pressure
Comments: ______
______
______
OUTCOME ASSESSMENT
Did patient develop ACS at any time? / ACS:Yes No If “Yes” to ACS, please explain:
______
Was a decompressive laparotomy necessary (includes temporary abdominal closure)? / Yes No
If decompressive laparotomy was necessary, please explain:
______
Did the patient develop evidence of
aspiration as a result of their head beingflat (i.e., 0 degrees)? / Yes No
If“Yes” to aspiration, please explain:
______
Patient outcome at ICU discharge? / Alive
Dead
Ventilator dependent
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RICHMOND AGITATION SEDATION SCORE (RASS)
Score / Term / Description+4 / Combative / Overtly combative or violent; immediate danger to staff
+3 / Very agitation / Pulls on or removes tube(s) or catheter(s) or has aggressive behaviortoward staff
+2 / Agitated / Frequent nonpurposeful movement or patient–ventilator dyssynchrony
+1 / Restless / Anxious or apprehensive but movements not aggressive or vigorous
0 / Alert and calm
-1 / Drowsy / Not fully alert, but has sustained (more than 10 seconds) awakening,with eye contact, to voice
-2 / Light sedation / Briefly (less than 10 seconds) awakens with eye contact to voice
-3 / Moderate sedation / Any movement (but no eye contact) to voice
-4 / Deep sedation / No response to voice, but any movement to physical stimulation
-5 / Unarousable / No response to voice or physical stimulation
SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA) SCORE
Determine score based upon the 24 hour period prior to the first study IAP measurement.
Add the points for each of the six (6) variables to determine the total SOFA score.
Variable / 0 / 1 / 2 / 3 / 4PaO2/FiO2 (mmHg) / > 400 / ≤ 400 / ≤ 300 / ≤ 200 / ≤ 100
Platelets (103/L) / > 150 / ≤ 150 / ≤ 100 / ≤ 50 / ≤ 20
Bilirubin (mg/dL) / < 1.2 / 1.2-1.9 / 2.0-5.9 / 6.0-11.9 / > 12
Hypotension / None / MAP < 70 mmHg / Dopamine ≤ 5 / Dopamine > 5
Dobutamine > 5
Dopexamine > 5
Epinephrine ≤ 0.1
Norepinephrine ≤ 0.1 / Dopamine > 15
Dobutamine > 15
Dopexamine > 15
Epinephrine> 0.1
Norepinephrine> 0.1
Vasopressin (any dose)
Glascow Coma Score / 15 / 13-14 / 10-12 / 6-9 / < 6
Creatinine (mg/dL) / < 1.2 / 1.2-1.9 / 2.0-3.4 / 3.5-4.9 / > 5
Drug dosages in mcg/kg/min
TOTAL SOFASCORE = ______
SAPS-2 SCORE WORKSHEET
Step 1: Determine the Admission Type pointsAdmission type points: ______
- Surgery scheduled more than 24hours before admission (0 points)
- Medical - no surgery within one week of admission (6 points)
- Unscheduled surgery (8 points)
Step 2: Determine the Chronic Illness pointsChronic illness points: ______
- Documented metastatic cancer (9 points)
- Lymphoma, leukemia, multiple myeloma (10 points)
- Clinical AIDS (HIV + with symptoms) (17 points)
Step 3: Calculate the Physiologic pointsPhysiologic points: ______
Circle the appropriate range for the worst value within the 24 hours prior to thefirst study IAP measurement. Add the points for each physiological variable to determine the total Physiologic points.
Variable Points: / 26 / 13 / 12 / 11 / 9 / 7 / 6 / 5 / 4 / 3 / 2 / 0 / 1 / 2 / 3 / 4 / 6 / 7 / 9 / 10 / 12 / 15 / 16 / 18Age (years) / <40 / 40-59 / 60-69 / 70-74 / 75-79 / 80
Temperature (C) / <39 / 39
Heart Rate (bpm) / <40 / 40-69 / 70-119 / 120-159 / 160
Systolic BP (mmHg) / <70 / 70-99 / 100-199 / 200
Serum Na (mEq/L) / <125 / 125-144 / 145
Serum K (mEq/L) / <3.0 / 3.0-4.9 / 5.0
HCO3 (mEq/L) / <15 / 15-19 / 20
BUN (mg/dL) / <28 / 28-83 / 84
WBC / <1.0 / 1.0-19.9 / >20
Bilirubin (mg/dL) / <4.0 / 4.0-5.9 / 6.0
PaO2/FiO2 / <100 / 100-199 / 200
GCS / <6 / 6-8 / 9-10 / 11-13 / 14-15
Urine output (mL/d) / <500 / 500-999 / 1000
TOTAL SAPS-2 SCORE = Admission Type points + Chronic illness points + Physiologic points: ______
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APACHE II SCORE WORKSHEET
Step 1: Calculate the total Acute Physiology Score
Circle the appropriate range for the worst value within the first 24 hoursprior to thefirst study IAP measurement.. Add the points determined for each physiological variable to determine the total Acute Physiology Score.
+4 / +3 / +2 / +1 / 0 / +1 / +2 / +3 / +4Rectal temp (C) / >41 / 39-40.9 / 38.5-38.9 / 36-38.4 / 34-35.9 / 32-33.9 / 30-31.9 / <29.9
Mean arterial pressure (mmHg) / >160 / 130-159 / 110-129 / 70-109 / 50-69 / <49
Heart rate (bpm) / >180 / 140-179 / 110-139 / 70-109 / 55-69 / 40-54 / <39
Respiratory rate (bpm) / >50 / 35-49 / 25-34 / 12-24 / 10-11 / 6-9 / <5
Oxygenation
If intubated and FiO2 ≥ 0.50, use AaDO2*
If intubated and FiO2 < 0.50, use PaO2 / >500 / 350-499 / 200-349 / < 200
>70 / 61-70 / 55-60 / <50
Arterial pH / >7.7 / 7.6-7.69 / 7.5-7.59 / 7.3-7.49 / 7.25-7.3 / 7.15-7.24 / < 7.15
Serum sodium (mmol/l) / >180 / 160-179 / 155-159 / 150-154 / 130-149 / 120-129 / 111-119 / <110
Serum potassium (mmol/l) / >7 / 6-6.9 / 5.5-5.9 / 3.5-5.4 / 3-3.4 / 2.5-2.9 / <2.5
Serum creatinine (mg/dl)
(Double score for acute renal failure) / >3.5 / 2-3.4 / 1.5-1.9 / 0.6-1.4 / <0.6
Haematocrit (%) / >60 / 50-59.9 / 46-49.9 / 30-45.9 / 20-29.9 / < 20
White cell count (103/ml) / >40 / 20-39.9 / 15-19.9 / 3-14.9 / 1-2.9 / < 1
Glascow Coma Score (GCS) / Score = 15 minus actual GCS ______
Serum HCO3 (mmol/L)(only if no ABG) / ≥ 52 / 41-51.9 / 32-40.9 / 22-31.9 / 18-21.9 / 15-17.9 / < 15
* AaDO2 = (FiO2 x 713)-PaO2 – PaCO2
TOTAL ACUTE PHYSIOLOGY SCORE: ______
APACHE II SCORE WORKSHEET (CONTINUED)
Step 2: Determine the Age points from the table below
Age / Points<44 / 0
45-54 / 2
55-64 / 3
65-74 / 5
>75 / 6
Step 3: Calculate the Chronic Health points for each of the five organ systems
Note: Organ insufficiency or immunocompromised state must have preceded the current admission.
History of severe organ insufficiency / PointsNon-operative patients / 5
Emergency postoperative patients / 5
Elective postoperative patients / 2
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- ImmunocompromisedScore = ______
- Receiving therapy that suppresses host defences (immunosuppression, chemotherapy, radiation therapy, long term steroid use, high dose steroid therapy) or
- Has a disease interfering with immune function such as malignant lymphoma or leukaemia
- Hepatic insufficiencyScore = ______
- Biopsy proven cirrhosis
- Portal hypertension
- Episodes of upper GI bleeding due to portal hypertension
- Prior episodes of hepatic failure, coma or encephalopathy
- Cardiovascular insufficiencyScore = ______
- New York Heart Association Class IV
- Respiratory insufficiencyScore = ______
- Severe exercise restriction due to chronic restrictive, obstructive or vascular disease,
- Documented chronic hypoxia, hypercapnia, secondary polycythaemia, severe pulmonary hypertension
- Respirator dependency
- Renal insufficiencyScore = ______
- On chronic dialysis
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Zero Reference points:
Reference points should be marked on the skin of the patient before the first measurement with either a permanent marker or tape (study site specific) with the patient in supine position without a pillow.
- The midchest reference point (phlebostatic axis) is located one half of the patient’s anteroposterior diameter below the sternal angle.
- The mid-iliac crest reference point is at the crossing of the midaxillary line and an imaginary line, perpendicular to the previous one, going through the top of the iliac crests.
- The symphysis pubis reference point is at the anterior border of the symphysis pubis.
Technique for IAP measurement
IAP will be measured using the transvesical technique, after instillation of 20mL of saline into the bladder, using an AbViser kit (Wolfe-Tory Medical, Salt Lake City, UT, USA), and connected to the monitoring equipment available in the unit. To standardize IAP measurement technique, Wolfe-Tory will provide the AbViser bladder monitoring kits to study sites that do not currently utilize this device free of charge.
Measurement Protocol - **REVISED**
- With the AbViser device connected to the patient’s urinary catheter, place the patient in the first position listed in the IAP measurement table (i.e., supine, 15º head of bed (HOB) elevation , or 30º HOB elevation).
- Clamp the drainage tubing by turning the AbViser valve so that the red and green marks align.
- Instill 20 mL of sterile saline into the bladder.
- Zero the transducer at the first reference point listed in the table (i.e., symphysis pubis, mid-iliac crest, or phlebostatic axis).
- Wait 30seconds and measure the IAP.
- Document the measured IAP in the appropriate box of the table.
- Re-zero the transducer at the second reference point in the table.
- Repeat steps 5 and 6.
- Re-zero the transducer at the third reference point in the table.
- Repeat steps 5 and 6.
- Record the mean arterial pressure, peak airway pressure, and mean airway pressure for that bed position.
- Unclamp the drainage tubing by aligning the green marks on the AbViser valve. Allow the bladder the drain completely.
- Place the patient in the second position listed in the IAP measurement table.
- Repeat steps 2 through 12 in the second patient position.
- Place the patient in the third position listed in the IAP measurement table.
- Repeat steps 2 through 12 in the third patient position.
- Return the patient’s HOB to the position of choice in the study site ICU.
- Subtract the volume of saline infused (20mL per position = 60 mL total) from the patient’s urinary output for that hour.
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STUDY DATA COLLECTION OVERVIEW
Study Entry / Measurement 1 / Measurement 2 / Measurement 3 / Study ConclusionScreening
- Informed consent OR
- Inclusion checklist
- Exclusion checklist
- APACHE-II score
- SOFA score
- SAPS-2 score
- Age
- Gender
- Weight
- Height
- ICU admission diagnosis
- Supine
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- 15º HOB elevation
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- 30º HOB elevation
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- RASS score
- PEEP level
- Mean arterial pressure
- Peak inspiratory pressure
- Mean airway pressure
- Abdomen status (open vs. closed)
- 15º HOB elevation
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- 30º HOB elevation
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- Supine
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- RASS score
- PEEP level
- Mean arterial pressure
- Peak inspiratory pressure
- Mean airway pressure
- Abdomen status (open vs. closed)
- 30º HOB elevation
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- Supine
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- 15º HOB elevation
- Symphysis pubis
- Iliac crest
- Phlebostatic axis
- RASS score
- PEEP level
- Mean arterial pressure
- Peak inspiratory pressure
- Mean airway pressure
- Abdomen status (open vs. closed)
- Occurrence of ACS at any time
- Need for decompression
- Occurrence of pulmonary aspiration
- Outcome at ICU discharge
IAH – Intra-Abdominal Hypertension, ACS – Abdominal Compartment Syndrome, HOB – head of bed, APACHE – Acute Physiology Chronic Health Evaluation, SOFA –Sequential Organ Failure Assessment, SAPS – Simplified Acute Physiology Score, RASS –Richmond Agitation Sedation Score, PEEP – positive end-expiratory pressure
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