Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pneupac VR1 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Manual ventilation with Mapleson C-circuit
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Pneupac VR1 portable ventilator
- interventionNames
- Device: Pneupac VR1
Primary outcomes (1)
- measure
- Pre- and post transfer partial pressure carbon dioxide measurements, from blood samples, taken from in-situ arterial line
- timeFrame
- Average (mean) 10 minutes
- description
- The difference in pCO2 between patients in the control and the intervention group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available