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

NCT05587179 | Completed

• 1 other identifier: RP-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Unconsciousness

Keywords

Recovery position; First aid for unconsciousness; Arterial flow

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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)

  after 15 min in the recovery position

• Pain (experienced by participant)

  after 15 min in the recovery position

• Skin discoloration

  after 15 min in the recovery position

Study Arms (2)

Lateral side-lying recovery position with extended arm

EXPERIMENTAL

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

Lateral side-lying recovery position with bent arms

ACTIVE COMPARATOR

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

Interventions

recovery position OTHER

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.

Lateral side-lying recovery position with bent arms; Lateral side-lying recovery position with extended arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Evidence-Based Practice, Belgium: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilde Heuten

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a cross-over Randomized Controlled Trial in which the sequence of the lateral recovery position will be randomized.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 19, 2022
• Study Start: December 21, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)