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

Primary Purpose

Unconsciousness

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
recovery position
Sponsored by
Centre for Evidence-Based Practice, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Unconsciousness focused on measuring Recovery position, First aid for unconsciousness, Arterial flow

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Antwerp University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lateral side-lying recovery position with extended arm

Lateral side-lying recovery position with bent arms

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in peripheral arterial pressure (PAP)
extracted from pulse wave amplitude (PWA) measured by radial artery tonometry
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
Peripheral venous pressure (PVP)
measured at the forearm and the back of the hand by venous congestion plethysmography

Secondary Outcome Measures

Oxygen saturation
Heart rate
Discomfort (experienced by participant)
10-point Likert-scale completed by the participants
Pain (experienced by participant)
10-point Likert-scale completed by the participants
Skin discoloration
10-point Likert-scale completed by the researcher

Full Information

First Posted
September 26, 2022
Last Updated
August 22, 2023
Sponsor
Centre for Evidence-Based Practice, Belgium
Collaborators
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT05587179
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Evidence-Based Practice, Belgium
Collaborators
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unconsciousness
Keywords
Recovery position, First aid for unconsciousness, Arterial flow

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lateral side-lying recovery position with extended arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Lateral side-lying recovery position with bent arms
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
recovery position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in peripheral arterial pressure (PAP)
Description
extracted from pulse wave amplitude (PWA) measured by radial artery tonometry
Time Frame
between 10 to 15 min in each position
Title
Cross-sectional area of the ulnar artery (SU) and peak systolic velocity of the ulnar artery (PSVU) of the hand of the dependent arm
Description
measured by echo doppler
Time Frame
between 10 to 15 min in each position
Title
Peripheral venous pressure (PVP)
Description
measured at the forearm and the back of the hand by venous congestion plethysmography
Time Frame
between 10 to 15 min in each position
Secondary Outcome Measure Information:
Title
Oxygen saturation
Time Frame
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)
Title
Heart rate
Time Frame
measured continuously during 1u15min (15 min supine position, 15 min posture 1, 15 min supine position, 15 min posture 2, 15 min supine position)
Title
Discomfort (experienced by participant)
Description
10-point Likert-scale completed by the participants
Time Frame
after 15 min in the recovery position
Title
Pain (experienced by participant)
Description
10-point Likert-scale completed by the participants
Time Frame
after 15 min in the recovery position
Title
Skin discoloration
Description
10-point Likert-scale completed by the researcher
Time Frame
after 15 min in the recovery position

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmy De Buck
Phone
+32 15443514
Email
emmy.debuck@rodekruis.be
First Name & Middle Initial & Last Name or Official Title & Degree
Hilde Heuten
Phone
+32 3 821 30 00
Email
studiescardiologie@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Heuten
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilde Heuten
Phone
+32 3 821 30 00
Email
studiescardiologie@uza.be
First Name & Middle Initial & Last Name & Degree
Emmy De Buck, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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