Clinical trial NCT05587179: The Impact of Different Recovery Positions on the Perfusion of the Lower Forearm and Comfort
Official title: The Impact of Different Recovery Positions on the Perfusion of the Lower Forearm and Comfort Associated With the Positioning: a Cross-over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unconsciousness
Keywords: Recovery position
First aid for unconsciousness
Arterial flow
Lead sponsor: Centre for Evidence-Based Practice, Belgium
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2022-10-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a cross-over Randomized Controlled Trial in which the sequence of the lateral recovery position will be randomized.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

-healthy volunteers

Exclusion Criteria:

* History of any coronary or peripheral vascular disease such as Raynaud's disease or thromboangitis obliterans (self-declared)
* Type I or type II diabetes (self-declared)
* Intake of cholesterol-lowering medication (self-declared)
* High blood pressure (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg) and/or use of antihypertensive drugs (self-declared)
* Obesity (BMI \> 30 kg/m2)
* Smoking or using tobacco products (self-declared)

Primary outcomes:
measure: Difference in peripheral arterial pressure (PAP)
timeFrame: between 10 to 15 min in each position
measure: Cross-sectional area of the ulnar artery (SU) and peak systolic velocity of the ulnar artery (PSVU) of the hand of the dependent arm
timeFrame: between 10 to 15 min in each position
measure: Peripheral venous pressure (PVP)
timeFrame: between 10 to 15 min in each position
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 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)
measure: Heart rate
timeFrame: measured continuously during 1u15min (15 min supine position, 15 min posture 1, 15 min supine position, 15 min posture 2, 15 min supine position)
measure: Discomfort (experienced by participant)
timeFrame: after 15 min in the recovery position
measure: Pain (experienced by participant)
timeFrame: after 15 min in the recovery position
measure: Skin discoloration
timeFrame: after 15 min in the recovery position
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Hilde Heuten
role: PRINCIPAL_INVESTIGATOR
References: