Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation?

October 25, 2018 updated by: Ahmed Aljomah

Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation? A Randomized Controlled Study

Abstract:

Background: Circumferential negative pressure wound therapy (CNPWT) is commonly used to manage wounds and enhance the healing process. A theoretical concern was recently raised that CNPWT may have a negative effect on perfusion distally. Objectives: We aim to evaluate the effect of circumferential negative pressure therapy (CNPT) on distal O2 saturation in healthy volunteers. Design: Randomized controlled non-inferiority study. Methods: Fourteen healthy adult volunteers with O2 saturation ≥95% (by index finger pulse oximetry) will be invited to participate in the study. After obtaining a written informed consent, CNPWT foam/dressing will be applied in a sandwich-like manner on the middle third of each arm and a negative intermittent pressure of 125 mmHg will be applied to one arm chosen randomly, using the contralateral arm as control. The pressure will be applied 5 minutes on and 2 minutes off for 9 hours. Individual's participation will be terminated if O2 saturation drops below 92% at any study time. The outcome measure is index finger O2 saturation and will be checked every 30 minutes using a pulse oximetry. The area under the curve (AUC) of O2 saturation in the 2 arms will be compared using ANCOVA. Sample size was calculated to have 90% power, assuming a type one error of 5%, non-inferiority margin of 24 (mean AUC difference), SD of 20, and drop out of 2 participants. Importance: The study is expected to provide conclusive evidence on the effect of intermittent CNPT on distal O2 saturation. The results would have direct implications for CNPWT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of circumferential negative pressure therapy (CNPT) on distal O2 saturation in healthy volunteers.

Design and Methodology:

Design: This is a randomized controlled non-inferiority study.

Recruitment: Volunteers will be recruited through advertisement in King Faisal Specialist Hospital & Research Centre and other hospitals in Riyadh.

Pre-study procedures: After obtaining a well documented medical history each volunteer will undergo a full physical examination as well as an in-depth upper limb examination and comprehensive evaluation (including a pre-study index finger O2 saturation and upper limbs circumference measurements), the following data will be also collected: age, sex, height&weight, body mass index, and vital signs.

Procedures: CNPWT foam and dressing (in accordance to manufacturer's instructions) will be applied in a sandwich-like manner on the middle third of each arm, and a negative intermittent pressure of 125 mmHg will be applied to one arm chosen randomly, using the contralateral arm as control. The pressure will be applied 5 minutes on and 2 minutes off for 9 hours. Individual's participation will be terminated if O2 saturation by pulse oximetry drops below 92% at any study time.

Statistical analysis: The area under the curve (AUC) of O2 saturation will be compared between the 2 arms using ANCOVA.

Randomization schedule: a randomization schedule will be generated by an online program (www.randomization.com). Block randomization will be used.

Sample size: Fourteen adult volunteers will be invited to participate in the study.

The sample size for the study was calculated to have 90% power, assuming a type one error of 5%, non-inferiority margin of 24 (mean AUC difference), SD of 20, and drop out of 2 participants.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12713
        • King Faisal Specialist Hospital & Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult volunteers with O2 saturation ≥95% by pulse oximetry. Potential volunteers will be screened by routine medical history and physical examination and an in-depth upper limb examination

Exclusion Criteria:

  • Unhealthy individual
  • Chronic conditions
  • History of upper limb diseases or defects.
  • History of upper limb Surgical intervention.
  • History of upper limb implants.
  • Pre-study O2 saturation in either indices of less than 95%
  • Congenital or Traumatic upper limb defect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Negative pressure

Negative pressure system is applied with negative pressure (Active)

at a participant's unilateral arm
Device: Negative Pressure System
Negative Pressure System is a non-invasive system that applies sub-atmospheric(Negative) pressure, through a foam and an air-tight film dressing which is connected by suction tubes to a controller unit by which the primary negative pressure can be adjusted.
NO_INTERVENTION: No negative pressure

Negative pressure system is applied without negative pressure (Inactive)

at a participant's contralateral arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC) of index finger O2 saturation over 9 hours.
Time Frame: 9 hours
Index finger O2 saturation will be checked every 30 minutes using a pulse oximetry, from zero hour of the study until the end of the 9th hour, then AUC will be calculated.
9 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Aljomah

Investigators

  • Principal Investigator: Muhammad M Hammami, MD, PHD, King Faisal Specialist Hospital & Research Centre
  • Principal Investigator: Ahmed S Aljomah, MD, King Faisal Specialist Hospital & Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2018

Primary Completion (ACTUAL)

September 4, 2018

Study Completion (ACTUAL)

September 4, 2018

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (ACTUAL)

April 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

open access after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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