Skip to main content

Table 1 Variables and timeline for inclusion by each ICU. The complete timeline for each ICU is about 3–4 months

From: Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

Variables and time to collection

1–4 Months by ICU

Variable to be obtained in each ICU

Type of variable by ICU by Intervention and Control

Months 1 to 4

T1√

T2√

T3√

T4√

T1√

T2√

T3√

T4√

1-Primary Outcome

Development of new pressure ulcers in clusters:

▪ Areas defined of injury: sacrum, heels, ankles, elbows, hip, scapula

▪ Others

Rate ulcers per ICU /total control

Rate ulcers per ICU/total intervention

Median (IQR).

Stage of ulcers: I, II, III, IV + o Indeterminate

Total ulcers per stage per ICU per group /150 patients

N (%) by cluster

1–4 Months by ICU

T1√

T2√

T3√

T4√

T1√

T2√

T3√

T4√

2-Secondary Outcome

Complications during repositioning

Categorical: Hemodynamic changes, Respiratory Changes, ventilator changes, others.

Risk of PU in individuals

Hazard ratio (HR)

Date of appearance of the PU (day-month-year)

Time to the event (survival analysis)

1–4 Months by ICU

T1√

T2

T3

T4

T1√

T2

T3

T4

Variables to be controlled as possible confusion variables

Old PUs identified upon entry to ICU (presents at the baseline).

▪ Other injuries such as burns, mask injuries, tube injuries, surgical wound dressings

In ICU, PUs or dressing site (foam, hydrocolloid)

Total of patients with PUs up-to-baseline/150 patients by cluster (variable to be controlled)

N(%)

1–4 Months by ICU

T1√

T2

T3

T4

T1√

T2

T3

T4

3-Characteristics of patients [demographic, Health status,

Age (years), sex (M, F)

Mean (SD),

N(%)

Body Mass Index (BMI)

Median (interquartile range) or mean (SD)

Patients´ Weight at admission

Median (interquartile range, IQR) or mean (SD)

Patients´ Height at admission

Median (interquartile range, IQR) or mean (SD)

Type of comorbidity to patient admission: Cardiovascular condition, Respiratory condition, Diabetes, Neurological, Malignancy of Carcinoma, Kidney Disease, Peripheral Vascular Disease, Cerebrovascular Accident, Transplant, dermatitis o eczema, documented malnutrition on admission, others.

N(%)

Length of hospital stay in ICU (Hours, days) (admission to ICU-Discharge from ICU)

Date: day/month/year

Median (interquartile range, IQR) or mean (SD)

Patient-days involved in the study (by cluster and

Median (interquartile range, IQR) or mean (SD)

1–4 Months by ICU

T1√

T2√

T3√

T4√

T1√

T2√

T3√

T4√

4-Complications of patients in ICU

Cardiovascular, neurological, sepsis, respiratory, delirium, TEP, musculoskeletal, shock, death

N(%)

4-Dates of the possible end of the following in ICU

First ambulation in ICU

Transference to hospital service

Hospital transference

Death

Day/Month/Year

1–4 Months by ICU

T1√

T2

T3

T4

T1√

T2

T3

T4

5-Characteristics of the cluster (or ICU)

Type of hospital: Public, Private, University, other

N (%)

Skin Care Group

Preventive care use-report on medical history

N (%)

Care guide or policy

Institutional Preventive (Yes-No)

Name of guideline

N (%)

Professional Nurses per shift

Median ó mean (interquartile range IQR)

Auxiliares per shift

Median ó mean (interquartile range, IQR)

1–4 Months by ICU

T1√

T2√

T3√

T4√

T1√

T2√

T3√

T4√

6-Intervention Characteristic

Adherence in ICU to intervention

Compliance day by day (yes = 1, no = 2)

% compliance (calculated from 80% days stay per patient)

▪ Number of times one patient is mobilized in the intervention

▪ Description of the teams (total number of people who mobilized the patient)

▪ Total number of teams repeating intervention per shift

▪ The number of head and auxiliary nurses per team.

Acceptance of the final intervention of the study

Evaluation of the acceptability of the intervention by the personnel

Description of usual or conventional care by ICU

Descriptive

Individual __or group__

Frequency per shift__

Position variation: yes_ No_

Descriptive.