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

Unconsciousness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05587179
• Other study ID #: RP-001
• Status: Completed
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Centre for Evidence-Based Practice, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Unconsciousness

Intervention

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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Evidence-Based Practice, Belgium	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	Discomfort (experienced by participant)	10-point Likert-scale completed by the participants	after 15 min in the recovery position
Secondary	Pain (experienced by participant)	10-point Likert-scale completed by the participants	after 15 min in the recovery position
Secondary	Skin discoloration	10-point Likert-scale completed by the researcher	after 15 min in the recovery position