Postoperative Respiratory ComplicationsNCT04276584
Effect of Speaking Aloud After Abdominal Surgery.
A study testing Positive expiratory pressure and Speaking loudly during about 3 minutes in people with Postoperative Respiratory Complications, run by Umeå University at 1 site in Sweden.
Trial summary
Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Complications
- What is being tested?
- Positive expiratory pressure and Speaking loudly during about 3 minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 20 Feb 2020to 31 Jul 2020
- 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
- Performed abdominal surgery within 2 days at the departments of surgery, urology or gynecology at Umeå university hospital
Who cannot join
- Patients referred to ICU because of immediate postoperative complications.
- Patients who are unable to perform 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
Official title: Effect of Speaking Aloud vs. Positive Expiratory Pressure Therapy on Oxygen Saturation After Abdominal Surgery.
Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. In a cross-over design, 50 subjects will be randomized to start with either positive expiratory pressure maneuvers, i.e. deep inspiration followed by expiration in a positive expiratory pressure device at 10-15 cm of water, or to start with reading a text loudly. Arterial blood gases will be taken at study start. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry, and online transcutaneous carbon dioxide partial pressure measurements (SenTec Digital monitoring systems). Main outcome measurements include oxygen saturation after speaking compared with positive expiratory pressure therapy.
Read the detailed description
Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery, but there is a lack of evidence of effect. En passant, we observed that oxygen saturation was improved when patients talked postoperative day 1. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery.
It was estimated that a sample size of 34 patients was needed to detect a mean and (SD) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous carbon dioxide partial pressure of 0.5 kPa (1 kPa) with a significance level of 0.05 and a power of 0.8.
In a randomized controlled trial, 50 subjects will be randomized (1:1) to start with either positive expiratory pressure maneuvers, i.e. 3 x 10 deep inspiration followed by expiration in a positive expiratory pressure device of 10-15 cm H20 or to start with reading a text loudly during 3 minutes. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry. SenTec Digital Monitoring systems for online transcutaneous carbon dioxide partial pressure measurements.
- Conditions
- Postoperative Respiratory Complications
- Being tested
- Positive expiratory pressure, Speaking loudly during about 3 minutes
- Keywords
- abdominal surgery, hypoxia, lung function, ventilation, Carbon dioxide partial pressure, oxygen situation, Postoperative, Positive expiratory pressure therapy
- Medical subject headings
- Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive expiratory pressureDevice
Three blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm of water pressure. Repeated three times. Estimated time of 3 minutes time.
Speaking loudly during about 3 minutesOther
A specified swedish text
| Study group | Role | What they receive |
|---|---|---|
| Positive expiratory pressure | Active comparator | Deep inspiration followed by expiration to a resistance of 10-15 cm of water pressure. Done three times, each time with 10 inspiration/expiration cycles Receives: Device: Positive expiratory pressure |
| Speaking loudly | Experimental | Speaking loudly during 3 minutes. Receives: Other: Speaking loudly during about 3 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation after speaking aloud
Oxygen saturation (SaO2) at 7 minutes after speaking aloud compared with positive expiratory pressure therapy
Measured: At day 1 or 2 after surgery
Secondary outcomes (1)
Ventilation after speaking aloud
Transcutaneous carbon dioxide partial pressure after speaking aloud compared with positive expiratory pressure therapy
Measured: At day 1 or 2 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start20 Feb 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory ComplicationsStudies 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 is given to patients after abdominal surgery in order to improve postoperative oxygen saturation and lung function. We aim to test whether speaking loudly from a given text improve postoperative oxygen saturation and ventilation. 50 patients will be investigated in a randomized controlled trial with cross-over design starting either with positive expiratory pressure therapy (10 times 3 inspiration and expiration to positive expiratory pressure) or with speaking loudly from a given text.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Responsible party
- Sponsor
- Investigators
- Karl A Franklin, MD, Prof, Principal investigator, Dept Surgical and periopertive sciences, Umeå university, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276584
- Sponsor's protocol ID
- 201822831
- Status last verified
- Jan 2024
- First submitted
- 10 Feb 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To share all the measured data from each participant.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Speaking Aloud vs. Positive Expiratory Pressure Therapy on Oxygen Saturation After Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT04276584
- Acronym / sponsor ID
- 201822831
- Conditions
- Postoperative Respiratory Complications
- Keywords
- abdominal surgery, hypoxia, lung function, ventilation, Carbon dioxide partial pressure, oxygen situation, Postoperative, Positive expiratory pressure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 19 Feb 2020 (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.
Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. In a cross-over design, 50 subjects will be randomized to start with either positive expiratory pressure maneuvers, i.e. deep inspiration followed by expiration in a positive expiratory pressure device at 10-15 cm of water, or to start with reading a text loudly. Arterial blood gases will be taken at study start. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry, and online transcutaneous carbon dioxide partial pressure measurements (SenTec Digital monitoring systems). Main outcome measurements include oxygen saturation after speaking compared with positive expiratory pressure therapy.
Detailed description
Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery, but there is a lack of evidence of effect. En passant, we observed that oxygen saturation was improved when patients talked postoperative day 1. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery.
It was estimated that a sample size of 34 patients was needed to detect a mean and (SD) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous carbon dioxide partial pressure of 0.5 kPa (1 kPa) with a significance level of 0.05 and a power of 0.8.
In a randomized controlled trial, 50 subjects will be randomized (1:1) to start with either positive expiratory pressure maneuvers, i.e. 3 x 10 deep inspiration followed by expiration in a positive expiratory pressure device of 10-15 cm H20 or to start with reading a text loudly during 3 minutes. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry. SenTec Digital Monitoring systems for online transcutaneous carbon dioxide partial pressure measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Positive expiratory pressure is given to patients after abdominal surgery in order to improve postoperative oxygen saturation and lung function. We aim to test whether speaking loudly from a given text improve postoperative oxygen saturation and ventilation. 50 patients will be investigated in a randomized controlled trial with cross-over design starting either with positive expiratory pressure therapy (10 times 3 inspiration and expiration to positive expiratory pressure) or with speaking loudly from a given text.
| Arm | Type | Receives |
|---|---|---|
| Positive expiratory pressure | Active comparator | Device: Positive expiratory pressureDeep inspiration followed by expiration to a resistance of 10-15 cm of water pressure. Done three times, each time with 10 inspiration/expiration cycles |
| Speaking loudly | Experimental | Other: Speaking loudly during about 3 minutesSpeaking loudly during 3 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Performed abdominal surgery within 2 days at the departments of surgery, urology or gynecology at Umeå university hospital
Key exclusion criteria (2 listed)
- Patients referred to ICU because of immediate postoperative complications.
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 pressureThree blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm of water pressure. Repeated three times. Estimated time of 3 minutes time. | Device | Positive expiratory pressure |
| Speaking loudly during about 3 minutesA specified swedish text | Other | Speaking loudly |
Primary outcome
Oxygen saturation after speaking aloud
Time frame: At day 1 or 2 after surgery
Oxygen saturation (SaO2) at 7 minutes after speaking aloud compared with positive expiratory pressure therapy
1 secondary outcome
Ventilation after speaking aloud
Time frame: At day 1 or 2 after surgery
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 12 Jan 2024.
- Individual participant dataSharing planned: Yes. To share all the measured data from each participant.
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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 A Franklin, MD, Prof principal investigator
Dept Surgical and periopertive sciences, Umeå university, Sweden
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 and Speaking loudly during about 3 minutes in people with Postoperative Respiratory Complications, 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 1 inclusion and 2 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 12 Jan 2024. 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. 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?
Oxygen saturation after speaking aloud (time frame: At day 1 or 2 after surgery). 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 12 Jan 2024.