Respiratory InsufficiencyNCT02173327
Helm CPAP Versus Mask CPAP After Major Abdominal Surgery
A study testing Continuously helm CPAP and Intermittent Mask CPAP in people with Respiratory Insufficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Continuously helm CPAP and Intermittent Mask CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Apr 2016
- Phase
- Interventional
- 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
- Elective major abdominal surgery
Who cannot join
- Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Christian R Mortensen, MD, 0045 35458736, christian.risby@regionh.dk
Christian R Mortensen, MD
About this study
Official title: Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery
Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC.
In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used routineously after major abdominal surgery.
Read more
Recently new devices has been designed, which give the opportunity tip deliver continuously CPAP with out interruptions because of presumed better comfort. Therefore better patient compliance.
No studies to date have investigated the possible benefit of using continuously helm CPAP versus the traditional intermittent mask CPAP after major abdominal surgery.
The investigators' study will investigate if there are any benefits with continuously Helm CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.
- Conditions
- Respiratory Insufficiency
- Being tested
- Continuously helm CPAP, Intermittent Mask CPAP
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuously helm CPAPDevice
6 hours
Intermittent Mask CPAPDevice
10min every 2 hour for 18 hours
| Study group | Role | What they receive |
|---|---|---|
| Continuously Helm CPAP | Other | Continuously helm CPAP for 6 hours Receives: Device: Continuously helm CPAP |
| Intermittent Mask CPAP | Other | Intermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative. Receives: Device: Intermittent Mask CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2
Measured 6,12 and 18 hours after surgery
Measured: 24 hours
Secondary outcomes (5)
V/Q mismatch
V/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative.
Measured: 24 hours
Postoperative complications
Pulmonal complications defined as; needs of oxygen therapy more than 3 days after surgery, pneumonia and x-ray verified atelektases within 30 days after surgery.
Measured: 30 days
Length of stay
Length of stay
Measured: 30 days
Admittance to the intensive care unit
If needed. Cause and length of stay in the intensive care unit i recorded.
Measured: 30 days
Mortality
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Vennick Marcussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian R Mortensen, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173327
- Sponsor's protocol ID
- RHPOTA-01
- Status last verified
- Jun 2014
- First submitted
- 18 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Osterkamp JTF, Strandby RB, Henningsen L, Marcussen KV, Thomsen T, Mortensen CR, Achiam MP, Jans O. Comparing the effects of continuous positive airway pressure via mask or helmet interface on oxygenation and pulmonary complications after major abdominal surgery: a randomized trial. J Clin Monit Comput. 2023 Feb;37(1):63-70. doi: 10.1007/s10877-022-00857-7. Epub 2022 Apr 16.
PubMed 35429325
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02173327
- Acronym / sponsor ID
- RHPOTA-01
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 24 Jun 2014 (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.
Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC.
In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used routineously after major abdominal surgery.
Recently new devices has been designed, which give the opportunity tip deliver continuously CPAP with out interruptions because of presumed better comfort. Therefore better patient compliance.
No studies to date have investigated the possible benefit of using continuously helm CPAP versus the traditional intermittent mask CPAP after major abdominal surgery.
The investigators' study will investigate if there are any benefits with continuously Helm CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuously Helm CPAP | Other | Device: Continuously helm CPAPContinuously helm CPAP for 6 hours |
| Intermittent Mask CPAP | Other | Device: Intermittent Mask CPAPIntermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective major abdominal surgery
Key exclusion criteria (1 listed)
- Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.
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 |
|---|---|---|
| Continuously helm CPAP6 hours | Device | Continuously Helm CPAP |
| Intermittent Mask CPAP10min every 2 hour for 18 hours | Device | Intermittent Mask CPAP |
Primary outcome
PaO2/FiO2
Time frame: 24 hours
Measured 6,12 and 18 hours after surgery
5 secondary outcomes
V/Q mismatch
Time frame: 24 hours
Postoperative complications
Time frame: 30 days
Length of stay
Time frame: 30 days
Admittance to the intensive care unit
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Derived from this study: PubMed 35429325Osterkamp JTF, Strandby RB, Henningsen L, Marcussen KV, Thomsen T, Mortensen CR, Achiam MP, Jans O. Comparing the effects of continuous positive airway pressure via mask or helmet interface on oxygenation and pulmonary complications after major abdominal surgery: a randomized trial. J Clin Monit Comput. 2023 Feb;37(1):63-70. doi: 10.1007/s10877-022-00857-7. Epub 2022 Apr 16.
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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.
Christian R Mortensen, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuously helm CPAP and Intermittent Mask CPAP in people with Respiratory Insufficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Jun 2014. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus V Marcussen, MD (0045 27597839, marcussen_klaus@yahoo.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02173327, which also lists 1 linked publication.
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 24 Jun 2014.