An interventional study of recovery position in Unconsciousness, sponsored by Centre for Evidence-Based Practice, Belgium. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Centre for Evidence-Based Practice, Belgium · Not applicable, Interventional, and Supportive care
Introduction: A side-lying recovery position is recommended when victims are unresponsive but breathing normally and, hence, do not require cardiopulmonary resuscitation. In 2021, the European Resuscitation Council (ERC) and the Belgian Red Cross-Flanders issued new guidelines which included the description of a modified recovery position to avoid problems in victims with joint stiffness and to overcome potential obstructed venous return in the dependent arm. Based on good practice insights, the dependent arm will now be extended and not bent to support the other arm. However, there is currently no evidence available to support a specific recovery position.
Objectives: The aim of this study is to assess the impact of different recovery positions on perfusion of the forearm and associated comfort.
Methods: In this cross-over randomized controlled trial, 24 healthy volunteers will be placed in either the lateral recovery position with extended dependent arm or with bent arm, and in the other position thereafter. Before and between both recovery positions, the volunteers will be positioned supine for 15 min. Several perfusion indices of the forearm will be non-or mildly invasively monitored in the respective recovery positions by radial artery tonometry, ulnar artery echo doppler and venous congestion plethysmography. Subjective participant's discomfort and pain will be assessed as well. Differences in continuous outcomes between the different recovery positions will be assessed with paired t-tests or wilcoxon signed-rank test.
Discussion: The benefit of lateral positioning of adults and children with decreased level of consciousness has been widely accepted despite limited supportive scientific evidence. We here will provide direct evidence (i) whether venous drainage in the dependent limb is impaired when positioning the victim in the lateral recovery position with bent arms and (ii) whether this potential complication can be minimized by extending the dependent arm. The major limitations of this study is that healthy volunteers, instead of non-responsive victims, are included as participants, and that the study will be performed in a highly controlled environment. Nevertheless, the generated insights will directly fuel evidence-based treatment recommendations regarding the recovery position in first aid settings, and fill a current gap in evidence.
89 studies on the registry are indexed under Unconsciousness; 11 are open to participants now.
This study's enrollment of 8 is below the median of 51 across 56 interventional studies indexed under Unconsciousness.
Browse Unconsciousness studies →Centre for Evidence-Based Practice, Belgium is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
-healthy volunteers
Exclusion Criteria:
The lateral side-lying recovery position with extended arm is directly based on the revised 2021 ERC guidelines recommending to extend the dependent arm and placing it next to the creased upper lying arm, which supports the head.
Other: recovery position
In the lateral side-lying recovery position with bent arms, the elbow of the dependent arm will now be bent with palm up and the far knee still flexed.
Other: recovery position
A side-lying recovery position is a first aid intervention that can be performed by laypeople when victims are unresponsive but breathing normally and, hence, do not require cardiopulmonary resuscitation.
Difference in peripheral arterial pressure (PAP)
extracted from pulse wave amplitude (PWA) measured by radial artery tonometry
Time frame: between 10 to 15 min in each position
Cross-sectional area of the ulnar artery (SU) and peak systolic velocity of the ulnar artery (PSVU) of the hand of the dependent arm
measured by echo doppler
Time frame: between 10 to 15 min in each position
Peripheral venous pressure (PVP)
measured at the forearm and the back of the hand by venous congestion plethysmography
Time frame: between 10 to 15 min in each position
Oxygen saturation
Time frame: measured continuously during 1u15 min (15 min supine position, 15 min posture 1, 15 min supine position, 15 min posture 2, 15 min supine position)
Heart rate
Time frame: measured continuously during 1u15min (15 min supine position, 15 min posture 1, 15 min supine position, 15 min posture 2, 15 min supine position)
Discomfort (experienced by participant)
10-point Likert-scale completed by the participants
Time frame: after 15 min in the recovery position
Pain (experienced by participant)
10-point Likert-scale completed by the participants
Time frame: after 15 min in the recovery position
Skin discoloration
10-point Likert-scale completed by the researcher
Time frame: after 15 min in the recovery position
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Centre for Evidence-Based Practice, Belgium