Trial Outcomes & Findings for Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens (NCT NCT00847665)

NCT ID: NCT00847665

Last Updated: 2013-04-17

Results Overview

Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 330 participants
• Primary outcome timeframe: Intensive Care Unit (ICU) length of stay (days)
• Results posted on: 2013-04-17

Participant Flow

A medical-surgical ICU of a university hospital. Patients were recruited from february 2009 to January 2011

A total of 512 patients with more than 24 hours of mechanical ventilation were screened. 55 patients were excluded because of the presence of pressure ulcer. Other 126 patients were excluded because of the presence of other exclusion criteria (age, pregnancy, refusal of consent,...)

Participant milestones

Measure	Turning Every 4 Hours Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Overall Study STARTED	165	165
Overall Study COMPLETED	164	165
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Turning Every 4 Hours Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

Baseline characteristics by cohort

Measure	Turning Every 4 Hours n=165 Participants Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 Participants Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Total n=330 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants	81 Participants n=7 Participants	170 Participants n=5 Participants
Age, Categorical >=65 years	76 Participants n=5 Participants	84 Participants n=7 Participants	160 Participants n=5 Participants
Age Continuous	61 years STANDARD_DEVIATION 15 • n=5 Participants	62 years STANDARD_DEVIATION 14 • n=7 Participants	61 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	56 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	109 Participants n=7 Participants	220 Participants n=5 Participants
Region of Enrollment Spain	165 participants n=5 Participants	165 participants n=7 Participants	330 participants n=5 Participants

PRIMARY outcome

Timeframe: Intensive Care Unit (ICU) length of stay (days)

Population: Intention to treat

Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer

Outcome measures

Measure	Turning Every 4 Hours n=164 Participants Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 Participants Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Incidence of Pressure Ulcer (PU) Grade ≥ II	22 participants	17 participants

SECONDARY outcome

Timeframe: ICU length of stay (an average of 28 days)

ICU mortality (number of death in ICU)

Outcome measures

Measure	Turning Every 4 Hours n=164 Participants Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 Participants Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
ICU Mortality	51 participants	60 participants

SECONDARY outcome

Timeframe: icu length of stay

Time actually spent to manual repositioning by nurses team, in minutes/day

Outcome measures

Measure	Turning Every 4 Hours n=164 Participants Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 Participants Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Workload of Nurses	10.6 minutes per day Interval 7.9 to 14.9	20.8 minutes per day Interval 14.4 to 27.4

SECONDARY outcome

Timeframe: ICU length of stay

Time from initiation to withdrawal of mechanical ventilation. Days

Outcome measures

Measure	Turning Every 4 Hours n=164 Participants Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 Participants Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Length of Mechanical Ventilation (MV)	8 days Interval 5.0 to 15.0	7 days Interval 3.0 to 15.0

Adverse Events

Turning Every 4 Hours

Serious events: 15 serious events

Other events: 50 other events

Deaths: 0 deaths

Turning Every 2 Hours

Serious events: 23 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Measure	Turning Every 4 Hours n=164 participants at risk Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 participants at risk Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Respiratory, thoracic and mediastinal disorders unplanned extubation	6.7% 11/164 • Number of events 11 • 2 year ICU length of stay for each patient	11.5% 19/165 • Number of events 19 • 2 year ICU length of stay for each patient
Surgical and medical procedures Loss of medical devices	7.3% 12/164 • Number of events 12 • 2 year ICU length of stay for each patient	9.1% 15/165 • Number of events 15 • 2 year ICU length of stay for each patient

Other adverse events

Measure	Turning Every 4 Hours n=164 participants at risk Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt	Turning Every 2 Hours n=165 participants at risk Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
Respiratory, thoracic and mediastinal disorders Endotracheal tube obstruction	30.5% 50/164 • Number of events 50 • 2 year ICU length of stay for each patient	36.4% 60/165 • Number of events 60 • 2 year ICU length of stay for each patient

Additional Information

Dr. Francisco Manzano

University Hospital Virgen de las Nieves

Phone: 34958020125

Email: fmanzano@mailpersonal.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place