Study Stopped
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RCT: Compare - Pneupac VR1 to Manual Ventilation in Intubated Patients
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
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2016
Shorter than P25 for not_applicable cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2016
CompletedFirst Posted
Study publicly available on registry
May 25, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 25, 2022
March 1, 2022
1 year
May 22, 2016
March 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pre- and post transfer partial pressure carbon dioxide measurements, from blood samples, taken from in-situ arterial line
The difference in pCO2 between patients in the control and the intervention group.
Average (mean) 10 minutes
Study Arms (2)
Control
NO INTERVENTIONManual ventilation with Mapleson C-circuit
Intervention
EXPERIMENTALPneupac VR1 portable ventilator
Interventions
A portable mechanical ventilator/resuscitator for medical personnel in the hospital, ambu-lance, fire, and police services.
Eligibility Criteria
You may qualify if:
- 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
- Undergoing Head and neck surgery, where routine care includes intubation, arterial line and post-operative transfer to intensive care unit intubated .
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Jennifer Boston
Guy's & St Thomas' Foundation NHS Trust R&D Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2016
First Posted
May 25, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share