Last reviewed · How we verify
NCT04299776
CirQPOD Shoulder Study
NA trial testing CirQPOD in Hypotension on Induction. Withdrawn.
28 March 2020
Quick facts
| Lead sponsor | Zoll Medical Corporation |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Start date | 28 January 2020 |
| Primary completion | 28 March 2020 |
| Estimated completion | 28 March 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CirQPOD
- Standard airway management
Conditions studied
- Hypotension on Induction — all drugs for Hypotension on Induction →
Sponsor
Zoll Medical Corporation — full company profile →
Who can join
18 and older, any sex, with Hypotension on Induction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves circulation in hypotensive animals and humans. By increasing systemic pressure and cerebral perfusion as well as promoting venous return, IPR therapy potentially improves cerebral oxygenation. The lower intrathoracic pressures may also reduce pulmonary artery pressure, although there is currently little evidence one way or the other. Use of an ITPR can counteract the multifactorial intraoperative hypotension common during surgeries under general anesthesia, and reduce the need for other measures to treat such hypotension; however, they might simultaneously promote pulmonary complications. The investigators will therefore assess whether the use of intrathoracic pressure regulation in adults having shoulder surgery under general anesthesia in the sitting position reduces vasoactive medication requirements compared with routine clinical practice. Simultaneously, the investigators will assess the effect of intrathoracic pressure regulation on pulmonary circulation, cerebral oxygenation, and postoperative atelectasis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04299776
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypotension on Induction
Currently open trials in the same condition.
- NCT07370103 — Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension A · recruiting
- NCT06841822 — The Impact of Ultrasound-Guided Superficial and Deep Paravertebral Nerve Blocks at the Superior Costotransverse Ligament · NA · recruiting
- NCT06787404 — Evaluation of Post-Induction Hypotension Treatment with PRAM Method · active not recruiting
Other Zoll Medical Corporation trials
Trials by the same sponsor.
- NCT06313840 — Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Re · completed
- NCT05505136 — Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based · completed
- NCT05604430 — Pre-hospital Ventilation Clinical Study · enrolling by invitation
- NCT05073354 — Rapid Treatment of Shock Without Trauma · completed
- NCT05013333 — AED 3 Post-Approval Study · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04299776 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zoll Medical Corporation
- Last refreshed: 27 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04299776.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing