Blood Gas Monitoring, TranscutaneousNCT03176589
Effect of PEP on Oxygen Saturation and Carbon Dioxide After Abdominal Surgery
A study testing positive expiratory pressure (PEP) and Deep breathing maneuvers in people with Blood Gas Monitoring, Transcutaneous, run by Umeå University at 1 site in Sweden.
Trial summary
Positive expiratory pressure( PEP) is routinely given to patients after surgery in order to improve lung function and oxygen saturation. There is, however, no evidence of effect on lung function, postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Gas Monitoring, Transcutaneous
- What is being tested?
- positive expiratory pressure (PEP) and Deep breathing maneuvers
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 12 Jun 2017to 31 Dec 2018
- 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
- Adult patients over 18 years of age who have undergone open or laparoscopic abdominal surgery.
- Patients receiving postoperative PEP are asked the day after surgery if they want to participate in the study.
Who cannot join
- Patients who cannot participate in using PEP or who do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Surgery, Inst of Surgical and Perioperative sciences
Umeå, Umea, 901 85
About this study
Positive expiratory pressure( PEP) is routinely given to patients after surgery in order to improve lung function and oxygen saturation. There is, however, no evidence of effect on lung function, postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). The investigators aim to test the immediate effects of PEP therapy on oxygen saturation and carbon dioxide after abdominal surgery. 80 patients will be investigated in RCT design with expiration using PEP or with expiration to a sham-PEP, a tube without resistance. At the end of the study we will also measure the effect of 10x3 deep breathing maneuvers without PEP or shamPEP. Primary outcome: Maximum and minimum levels of continuously measured oxygen saturation from pulse oximetry and transcutaneous carbon dioxide partial pressure during the trial.
Read the detailed description
Background Hypoxia, reduced lung function and atelectais are common after abdominal surgery and can be hazardous in patients with chronic hypoxia. Positive expiratory pressure (PEP) therapy or incentive spirometry are routinely given to patients after abdominal surgery to counteract atelectasis and improve oxygen saturation. Patients are instructed by a physiotherapist to take deep inspiratory breaths and expire in a PEP-device or PEP bottle. The method is used routinely in Swedish hospital and the patient breathes against 10-15 cm water resistance. This is repeated 10x3 ie 10 deep breaths and exhalation towards PEP then rest, breath, rest and another 10 breaths. This procedure should be done once an hour after surgery. The idea is that this will widen alveoli and abolish atelectasis, thus increasing the oxygen uptake and reducing the risk of postoperative complications.
There is no evidence of effect of PEP and incentive spirometry on postoperative pulmonary complications after abdominal surgery (Guimarães MMF, Tyson AF). Nevertheless, PEP therapy is used in Sweden and internationally. There were no studies found reporting the immediate effect of PEP on continuous oxygen saturation and carbon dioxide partial pressure after surgery.
Aims
What effect does PEP have on oxygen saturation and carbon dioxide partial pressure? What is the effect of deep breathing maneuvers on oxygen saturation and carbon dioxide partial pressure?
Methods
Inclusion: 80 adult patients over 18 years of age who have undergone open or laparoscopic abdominal surgery. Patients receiving postoperative PEP are asked to participate in the study at one or two days after after abdominal surgery.
Exclusion: Patients who cannot participate in using PEP or who do not agree to participate in the study.
Power calculation:.It was estimated that 34 patients were needed to detect a mean (SD) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous PCO2 of 0.5 kPa (1 kPa) with a significance of p < 0.05 and a power of 80%.
Design / Randomization: RCT study with cross-over design. Patients are randomized using computer programs, handled by a person outside the study, to either start with either PEP breathing 10x3 or sham-PEP breathing 10x3.
Method: Starting with lung function assessment to determine PEF (Mini Wright Clement Clarke). Then, application of continuous transcutaneous PCO2 / SaO2 (SenTec Digital Monitoring System, ResMed) and a respiratory belt around the chest detecting the respiratory rate. Data is recorded with computer equipment (Noxturnal T3, ResMed).
The patients are randomized to initiate with either 10x3 breaths using PEP therapy or 10x3 breaths using Sham PEP. After a rest period, patients switch to the second treatment (cross-over). At the end of the trial, all patients take 10X3 deep breaths without PEP or sham PEP.
At the start of the study, baseline level for SaO2 and TcPCO2 is recorded, and an arterial blood gas is recorded to calibrate the transcutaneous PCO2 measurement. Thereafter, the registration continues during breathing / blowing until the patient returns to its baseline values. New PEF examination is made after each study arm.
- Conditions
- Blood Gas Monitoring, Transcutaneous
- Being tested
- positive expiratory pressure (PEP), Placebo comparator, Deep inspiration and expression in a placebo tube without resistance, Deep breathing maneuvers
- Keywords
- positive expiratory pressure, oxygen saturation, abdominal surgery, carbon dioxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive expiratory pressure (PEP)Device
Patients take a deep inspiration followed by PEP expiration with an expiratory pressure of 10-15 cm H2O
Placebo comparator, Deep inspiration and expression in a placebo tube without resistanceDevice
Deep inspirations 3 times 10 and expiration in a placebo tube without expiratory resistance
Deep breathing maneuversOther
deep breathing maneuvers 3 times 10 breahs without any device at expiration
| Study group | Role | What they receive |
|---|---|---|
| sham PEP | Sham comparator | 3 cycles of 10 deep inspiration and expiration in a sham tube without expiratory resistance Receives: Device: Placebo comparator, Deep inspiration and expression in a placebo tube without resistance |
| PEP | Active comparator | 3 cycles of 10 deep inspiration followed by expiration with positive expiratory pressure (PEP) device or PEP bottle of 10-15 cm of water pressure Receives: Device: positive expiratory pressure (PEP) |
| deep breathing maneuvers | Experimental | 3 cycled of 10 deep breathing maneuvers without PEP or sham PEP Receives: Other: Deep breathing maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous blood gas measurements: transcutaneous pCO2
transcutaneous pCO2
Measured: once, within one hour
Secondary outcomes (2)
Pulse oximetry: oxygen saturation (SaO2)
oxygen saturation (SaO2)
Measured: once, within one hour
Lung function: PEF
Peak expiratory flow
Measured: once, within one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start12 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Gas Monitoring, TranscutaneousStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Positive expiratory pressure (PEP) therapy
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- Karl Franklin, Ass Prof, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176589
- Sponsor's protocol ID
- 2017/195-31
- Status last verified
- Nov 2020
- First submitted
- 24 May 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guimaraes MM, El Dib R, Smith AF, Matos D. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006058. doi: 10.1002/14651858.CD006058.pub2.
PubMed 19588380Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
PubMed 25607594
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PEP on Oxygen Saturation and Carbon Dioxide After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03176589
- Acronym / sponsor ID
- 2017/195-31
- Conditions
- Blood Gas Monitoring, Transcutaneous
- Keywords
- positive expiratory pressure, oxygen saturation, abdominal surgery, carbon dioxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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.
Positive expiratory pressure( PEP) is routinely given to patients after surgery in order to improve lung function and oxygen saturation. There is, however, no evidence of effect on lung function, postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). The investigators aim to test the immediate effects of PEP therapy on oxygen saturation and carbon dioxide after abdominal surgery. 80 patients will be investigated in RCT design with expiration using PEP or with expiration to a sham-PEP, a tube without resistance. At the end of the study we will also measure the effect of 10x3 deep breathing maneuvers without PEP or shamPEP. Primary outcome: Maximum and minimum levels of continuously measured oxygen saturation from pulse oximetry and transcutaneous carbon dioxide partial pressure during the trial.
Detailed description
Background Hypoxia, reduced lung function and atelectais are common after abdominal surgery and can be hazardous in patients with chronic hypoxia. Positive expiratory pressure (PEP) therapy or incentive spirometry are routinely given to patients after abdominal surgery to counteract atelectasis and improve oxygen saturation. Patients are instructed by a physiotherapist to take deep inspiratory breaths and expire in a PEP-device or PEP bottle. The method is used routinely in Swedish hospital and the patient breathes against 10-15 cm water resistance. This is repeated 10x3 ie 10 deep breaths and exhalation towards PEP then rest, breath, rest and another 10 breaths. This procedure should be done once an hour after surgery. The idea is that this will widen alveoli and abolish atelectasis, thus increasing the oxygen uptake and reducing the risk of postoperative complications.
There is no evidence of effect of PEP and incentive spirometry on postoperative pulmonary complications after abdominal surgery (Guimarães MMF, Tyson AF). Nevertheless, PEP therapy is used in Sweden and internationally. There were no studies found reporting the immediate effect of PEP on continuous oxygen saturation and carbon dioxide partial pressure after surgery.
Aims
What effect does PEP have on oxygen saturation and carbon dioxide partial pressure? What is the effect of deep breathing maneuvers on oxygen saturation and carbon dioxide partial pressure?
Methods
Inclusion: 80 adult patients over 18 years of age who have undergone open or laparoscopic abdominal surgery. Patients receiving postoperative PEP are asked to participate in the study at one or two days after after abdominal surgery.
Exclusion: Patients who cannot participate in using PEP or who do not agree to participate in the study.
Power calculation:.It was estimated that 34 patients were needed to detect a mean (SD) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous PCO2 of 0.5 kPa (1 kPa) with a significance of p < 0.05 and a power of 80%.
Design / Randomization: RCT study with cross-over design. Patients are randomized using computer programs, handled by a person outside the study, to either start with either PEP breathing 10x3 or sham-PEP breathing 10x3.
Method: Starting with lung function assessment to determine PEF (Mini Wright Clement Clarke). Then, application of continuous transcutaneous PCO2 / SaO2 (SenTec Digital Monitoring System, ResMed) and a respiratory belt around the chest detecting the respiratory rate. Data is recorded with computer equipment (Noxturnal T3, ResMed).
The patients are randomized to initiate with either 10x3 breaths using PEP therapy or 10x3 breaths using Sham PEP. After a rest period, patients switch to the second treatment (cross-over). At the end of the trial, all patients take 10X3 deep breaths without PEP or sham PEP.
At the start of the study, baseline level for SaO2 and TcPCO2 is recorded, and an arterial blood gas is recorded to calibrate the transcutaneous PCO2 measurement. Thereafter, the registration continues during breathing / blowing until the patient returns to its baseline values. New PEF examination is made after each study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Positive expiratory pressure (PEP) therapy
| Arm | Type | Receives |
|---|---|---|
| sham PEP | Sham comparator | Device: Placebo comparator, Deep inspiration and expression in a placebo tube without resistance3 cycles of 10 deep inspiration and expiration in a sham tube without expiratory resistance |
| PEP | Active comparator | Device: positive expiratory pressure (PEP)3 cycles of 10 deep inspiration followed by expiration with positive expiratory pressure (PEP) device or PEP bottle of 10-15 cm of water pressure |
| deep breathing maneuvers | Experimental | Other: Deep breathing maneuvers3 cycled of 10 deep breathing maneuvers without PEP or sham PEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over 18 years of age who have undergone open or laparoscopic abdominal surgery.
- Patients receiving postoperative PEP are asked the day after surgery if they want to participate in the study.
Key exclusion criteria (1 listed)
- Patients who cannot participate in using PEP or who do not agree to participate in the study.
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 |
|---|---|---|
| positive expiratory pressure (PEP)Patients take a deep inspiration followed by PEP expiration with an expiratory pressure of 10-15 cm H2O | Device | PEP |
| Placebo comparator, Deep inspiration and expression in a placebo tube without resistanceDeep inspirations 3 times 10 and expiration in a placebo tube without expiratory resistance | Device | sham PEP |
| Deep breathing maneuversdeep breathing maneuvers 3 times 10 breahs without any device at expiration | Other | deep breathing maneuvers |
Primary outcome
Transcutaneous blood gas measurements: transcutaneous pCO2
Time frame: once, within one hour
transcutaneous pCO2
2 secondary outcomes
Pulse oximetry: oxygen saturation (SaO2)
Time frame: once, within one hour
Lung function: PEF
Time frame: once, within one hour
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 10 Nov 2020.
- Background: PubMed 19588380Guimaraes MM, El Dib R, Smith AF, Matos D. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006058. doi: 10.1002/14651858.CD006058.pub2.
- Background: PubMed 25607594Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
- Individual participant dataSharing planned: No
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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.
Karl Franklin, Ass Prof principal investigator
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive expiratory pressure (PEP) and Deep breathing maneuvers in people with Blood Gas Monitoring, Transcutaneous, run by Umeå University at 1 site in Sweden.
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 2 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: finished, as of the sponsor's last update on 10 Nov 2020. 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 Sweden. 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.
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?
Transcutaneous blood gas measurements: transcutaneous pCO2 (time frame: once, within one hour). 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 NCT03176589, which also lists 2 linked publications.
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 10 Nov 2020.