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

Sponsor
Centre for Evidence-Based Practice, Belgium (Other)
Overall Status
Recruiting
CT.gov ID
NCT05587179
Collaborator
University Hospital, Antwerp (Other)
24
1
2
6.3
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: recovery position
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This study is a cross-over Randomized Controlled Trial in which the sequence of the lateral recovery position will be randomized.This study is a cross-over Randomized Controlled Trial in which the sequence of the lateral recovery position will be randomized.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Dec 21, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Difference in peripheral arterial pressure (PAP) [between 10 to 15 min in each position]

    extracted from pulse wave amplitude (PWA) measured by radial artery tonometry

  2. Cross-sectional area of the ulnar artery (SU) and peak systolic velocity of the ulnar artery (PSVU) of the hand of the dependent arm [between 10 to 15 min in each position]

    measured by echo doppler

  3. Peripheral venous pressure (PVP) [between 10 to 15 min in each position]

    measured at the forearm and the back of the hand by venous congestion plethysmography

Secondary Outcome Measures

  1. 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)]

  2. 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)]

  3. Discomfort (experienced by participant) [after 15 min in the recovery position]

    10-point Likert-scale completed by the participants

  4. Pain (experienced by participant) [after 15 min in the recovery position]

    10-point Likert-scale completed by the participants

  5. Skin discoloration [after 15 min in the recovery position]

    10-point Likert-scale completed by the researcher

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antwerp University Hospital Edegem Antwerp Belgium 2650

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Hilde Heuten, University Hospital, Antwerp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre for Evidence-Based Practice, Belgium
ClinicalTrials.gov Identifier:
NCT05587179
Other Study ID Numbers:
  • RP-001
First Posted:
Oct 19, 2022
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre for Evidence-Based Practice, Belgium
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023