Mechanical Ventilation ComplicationPhase 1/2NCT01621139
A Pilot Clinical Trial to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
A Phase 1/2 study testing Acupuncture in people with Mechanical Ventilation Complication, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included.
Who cannot join
- Children < 18 years of age
- Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication)
- Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP < 90 or > 180 mm Hg for longer than 2 continuous hours
- Patients who are pregnant or pre-menopausal
- Patients with expected survival less than 6 3 months
- Major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupuncture treatment areas.
- Patients with a pacemaker or other implanted electronic device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group
| Study group | Role | What they receive |
|---|---|---|
| Real acupuncture | Experimental | Real acupuncture group Receives: Procedure: Acupuncture |
| Sham acupuncture | Sham comparator | Sham acupuncture group Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
RASS (Richmond Agitation Sedation Scale)
Measured: baseline to six months
Secondary outcomes (2)
ABPS (Aberdeen Back Pain Scale)
Measured: baseline to six months
Pain Scale
Measured: baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621139
- Sponsor's protocol ID
- 09-001937
- Status last verified
- Nov 2013
- First submitted
- 29 Mar 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01621139
- Acronym / sponsor ID
- 09-001937
- Conditions
- Mechanical Ventilation Complication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real acupuncture | Experimental | Procedure: AcupunctureReal acupuncture group |
| Sham acupuncture | Sham comparator | Procedure: AcupunctureSham acupuncture group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included.
Key exclusion criteria (7 listed)
- Children < 18 years of age
- Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication)
- Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP < 90 or > 180 mm Hg for longer than 2 continuous hours
- Patients who are pregnant or pre-menopausal
- Patients with expected survival less than 6 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePatients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group | Procedure or surgery | Real acupuncture, Sham acupuncture |
Primary outcome
RASS (Richmond Agitation Sedation Scale)
Time frame: baseline to six months
2 secondary outcomes
ABPS (Aberdeen Back Pain Scale)
Time frame: baseline to six months
Pain Scale
Time frame: baseline to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
Related trials for Mechanical Ventilation Complication
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupuncture in people with Mechanical Ventilation Complication, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RASS (Richmond Agitation Sedation Scale) (time frame: baseline to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.