The Impact of Different Recovery Positions on the Perfusion of the Lower Forearm and Comfort

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

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.

Study Overview

• Status: Completed
• Conditions: Unconsciousness
• Intervention / Treatment: Other: recovery position

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral side-lying recovery position with extended arm; 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; 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.
Active Comparator: Lateral side-lying recovery position with bent arms; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in peripheral arterial pressure (PAP)	extracted from pulse wave amplitude (PWA) measured by radial artery tonometry	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	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	between 10 to 15 min in each position

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation		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		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	after 15 min in the recovery position
Pain (experienced by participant)	10-point Likert-scale completed by the participants	after 15 min in the recovery position
Skin discoloration	10-point Likert-scale completed by the researcher	after 15 min in the recovery position

Collaborators and Investigators

• Sponsor: Centre for Evidence-Based Practice, Belgium
• Collaborators: University Hospital, Antwerp
• Investigators: Principal Investigator: Hilde Heuten, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Recovery position; First aid for unconsciousness; Arterial flow
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness
• Other Study ID Numbers: RP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No