Suspended

A Randomised Control Trial to Compare the Pneupac VR1 Portable Ventilator and Manual Ven-tilation Via a Mapleson C- Circuit During the Intra-hospital Transfers of Intubated Patients

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What is being tested

Pneupac VR1

Device
Who is being recruted

Neoplasms

From 18 to 100 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: June 2016
See protocol details

Summary

Principal SponsorBrighton and Sussex University Hospitals NHS Trust
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

Following major head and neck surgery it may be necessary to keep patients intubated and ventilated for at least 12 hours to allow the swelling associated with the operation to subside. Therefore patients (participants) are transferred to the intensive care unit anaesthetised, in-tubated and ventilated. Current practice is that patients are manually ventilated, by hand, during transfer from the operating theatre to the intensive care unit. Studies show that use of manual ventilation causes variability in respiratory parameters and blood gas values due to inconsistent ventilation. A study in 2003 found that portable ventila-tor provided more consistent ventilation and patients were less likely to have a disparity in their blood gases, oxygenation and ventilation.. However, conventional ventilators are bulky, heavy, expensive and few and far between in the hospital and, in particular, the pre-hospital setting. The Pneupac VR1 ventilator is simple to use, small, portable and durable. It is easy to clean, low cost, light weight and magnetic resonance imaging (MRI) compatible. The study will aim to directly compare the efficiency and efficacy (ventilation rate and tidal volumes) of manual ventilation against a new device, VR-1 portable ventilator, by Smith-Medical. The device is CE approved. The RCT will compare the efficacy and efficiency during transfer of the patient from theaters to intensive care in our establishment. The endpoint will be arrival to the intensive care unit (ICU) and transfer onto the ICU ventilator. This will be measured by collecting the pCO2, taken from an already in-situ arterial blood gas (ABG), at two time points - (a) just before patient transfer from theaters to the intensive care unit and (b) upon arrival at the intensive care unit and just prior to transfer onto the ITU ventilator.

Official TitleA Randomised Control Trial to Compare the Pneupac VR1 Portable Ventilator and Manual Ven-tilation Via a Mapleson C- Circuit During the Intra-hospital Transfers of Intubated Patients
NCT02782871
Principal SponsorBrighton and Sussex University Hospitals NHS Trust
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

7 inclusion criteria required to participate
Participant is willing and able to give informed consent for participation in the study.

Male or Female, aged 18 years or above.

Elective surgery

ASA 1-3

Show More Criteria

4 exclusion criteria prevent from participating
The participant may not enter the study if ANY of the following apply:

Have refused consent to participate in trial

Emergency surgery

Those patients who do not require intubation, arterial line and/ or transfer to intensive care intubated as routine practice for type of surgery/ procedure being undertaken

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Pneupac VR1 portable ventilator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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