Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units

Pain Clinical Trial

— ASCyD  

Official title:

Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773874
• Other study ID #: PY 17/22
• Status: Completed
• Start date: February 12, 2018
• Est. completion date: March 11, 2018

Study information

• Verified date: February 2018
• Source: Hospital Universitario Getafe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study assess which Spanish intensive care units evaluate and record, in a standardized way, levels of pain, sedation / agitation, use of physical restraints and prevalence of delirium. Also determine the use of validated assessment tools and explore levels of pain and sedation / agitation, use of physical restraints and prevalence of delirium.

Description:

An observational, descriptive, cross-sectional, prospective and multicenter study was conducted to know the usual practice (audit) in critical care units and about the assessment of pain, sedation, delirium and the use of mechanical restraints.

At the same time, the level of pain, sedation / agitation and presence of delirium were evaluated in all adult patients who were admitted to the participating units with a minimum stay of 24 hours in the unit.

Process In order to obtain the largest representation of Spanish Intensive Care Units, a network of research nurses was created with coordinators in each autonomous community. The function of the coordinators was to contact and recruit units of adult critical patients within their community. Each coordinator contacted the centers (public and private), creating a network of collaborating nurses from those units who expressed their willingness to participate and who obtained the authorization of their Research Ethics Committee. Each unit was asked to contact a collaborating nurse for the project.

Once the national network of collaborating nurses was created, through the community coordinators, each password was given to each nurse to access the platform created for data entry. The platform offered access to all the documents (methodology, timeline, recommended assessment tools, navigation tutorial for the platform).

Data collection The tool used was an ad hoc survey with online access which consisted of 2 blocks. The first block asked about the characteristics of the units, the nurse-patient ratio, the existence of protocols and the usual practice for the control of pain, sedation / agitation, delirium and the use of mechanical restraints in the unit.

In the second block, questions were asked about aspects of direct assistance to patients, and direct evaluation of pain level, sedation / agitation of patients as well as the presence of delirium and mechanical containment.

Evaluation of patients included The data collection was done by direct observation and in the same period in all participating units. These data were entered into the platform through a "Patient Code", created automatically by the system.

To assess pain in patients, the investigators used two scales, for patients with the ability to communicate, the Visual Analogue Scale (VAS) scale was recommended and for patients without the ability to communicate the Scale of Behavioral Indicators of Pain (ESCID). The evaluation of the level of sedation / agitation was recommended to be carried out with the Richmond Agitation Sedation Scale (RASS) and delirium with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

The data on the use of tools to assess pain, sedation / agitation and delirium, as well as the recording of the use of mechanical restraints, were collected retrospectively on the nursing records of the patients evaluated, the day after their assessment.

Statistic analysis First, a descriptive analysis was made of the general characteristics of the participating units and the study population, presenting the data with means and standard deviations (SD) or medians and interquartile ranges (RIC), as appropriate. Group comparison was performed with the Student t test for quantitative variables or nonparametric tests, as appropriate, and Fischer's test or chi-square for qualitative variables. The data was analyzed with the statistical package IBM SPSS Statistics 21.0 for Windows

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1574
• Est. completion date: March 11, 2018
• Est. primary completion date: February 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients who were admitted to the participating units at the time of the audit and had a minimum stay of 24 hours in the unit.

Exclusion Criteria:

• no criteria

Related Conditions & MeSH terms

• Agitation
• Critical Care
• Delirium
• Nursing Assessment
• Pain
• Restraint, Physical
• Sedation

Intervention

Other:
• Assessment
Evaluation

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.	Primary assessment of pain. NRS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain	one day
Primary	"Non communicative" patient's pain with Behavioural Indicators of Pain Scale (ESCID) in critical care units.	Primary assessment of pain ESCID scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain	one day
Primary	Communicative and "no communicative" patient's sedation/agitation level's with Richmond Agitation Sedation Scale (RASS) in critcal care units.	Primary assessment of sedation/agitation level' s. RASS scale range from -5 to +5. -4 to -5: depth sedation; -3 to -1: light sedation; 0: aware; +1 to +4: agitation.	one day
Primary	Communicative and "no communicative" patient's delirium prevalence with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in critical care units	Primary assessment of delirium	one day
Primary	Use of physical restraints on Communicative and "no communicative" patient's in critical care units	Primary assessment of use of physical restraints	one day
Secondary	use of validated scale of pain: Numeric Rating Scale (NRS)	use of validated scales of pain for communicative patients. NRS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.	one day
Secondary	use of validated scale of pain: Visual Analog Scale (VAS)	use of validated scales of pain for communicative patients. VAS, scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.	one day
Secondary	use of validated scale of pain: Campbell scale	use of validated scales of pain for "non communicative" patients. Campbell scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.	one day
Secondary	use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)	use of validated scales of pain for "non communicative" patients. ESCID scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.	one day
Secondary	use of validated scales of pain: Behavioral Pain Scale (BPS)	use of validated scales of pain for "non communicative" patients. scale's range from 3 to 12; 3: no pain, high number more pain.	one day
Secondary	use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)	use of validated scales of pain for "non communicative" patients. CPOT: range from 0 to 8; 0-2: no pain, > 2 pain.	one day
Secondary	use of validated scales of sedation/agitation (RASS)	use of validated scales of sedation/agitation patients. RASS scale range from -5 to +5. -4 to -5: depth sedation; -3 to -1: light sedation; 0: aware; +1 to +4: agitation.	one day
Secondary	use of validated scales of sedation/agitation (Ramsay scale)	use of validated scales of sedation/agitation patients. Ramsay score from 1 to 6; 1: anxious, agitated restless, 2: cooperative, oriented, tranquil, 3: responsive to commands only, 4: brisk response to light glabellar tap or loud auditory stimulus, 5: sluggish response to light glabellar tap or loud auditory stimulus, 6: no response to light glabellar tap or loud auditory stimulus.	one day
Secondary	use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))	Use of validated scales of delirium. ICDSC is positive (delirium present) or negative (no delirium).	one day
Secondary	use of validated scales of delirium (CAM-ICU)	Use of validated scales of delirium. CAM-ICU is positive (delirium present) or negative (no delirium).	one day
Secondary	protocols of pain and sedation	Presence of protocols in the critical care units	one day
Secondary	protocols of use of physical restraints	Presence of protocols in the critical care units	one day
Secondary	protocols of management of delirium	Presence of protocols in the critical care units	one day