Abdominal SurgeryNCT04747535
Continuous Positive Airway Pressure After Abdominal Surgery
A study testing Auto-CPAP and CPAP since before in people with Abdominal Surgery and Continuous Positive Airway Pressure, run by Umeå University at 1 site in Sweden.
Trial summary
This is a randomized controlled trial with an allocation ratio of 1:1. Half the patients are randomized to continuous positive airway pressure (CPAP) and half to routine medical care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominal Surgery, Continuous Positive Airway Pressure, Lung Function
- What is being tested?
- Auto-CPAP and CPAP since before
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 10 May 2021to 31 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age 18-80 years) scheduled for elective abdominal surgery
- Must be able to tolerate nasal CPAP
Who cannot join
- American Society Anesthesia (ASA) Class 3-4.
- Cognitive impairment or dementia
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: Continuous Positive Airway Pressure After Abdominal Surgery -A Randomized Controlled Trial
This is a randomized controlled trial with an allocation ratio of 1:1. Half the patients are randomized to continuous positive airway pressure (CPAP) and half to routine medical care. Included are one hundred and twenty patients aged 18-80 years plus patients with ongoing CPAP scheduled for abdominal surgery at Umeå university hospital. The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery. Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery. PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP. All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery.
Patients in the CPAP treated group are given an auto-CPAP with a minimum pressure of 5 cm and a maximum pressure of 10 cm. They will be treated with CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%. Patients in the control group receives standard treatment and supplemental oxygen if oxygen saturation falls below 90%. In a third arm, we will include patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.
Read the detailed description
Theory Research question: Does nasal CPAP abolish postoperative hypoxia and lung function decline after abdominal surgery?
Methods This is a randomized controlled trial with an allocation ratio of 1:1. Half of the patients are randomized to CPAP and half to routine medical care. Randomization is generated by a computer program and handled by a person outside the study. Randomization procedure is documented by the contact person and in the patient's study protocol.
Include are one hundred and twenty patients age 18-80 years old, scheduled for abdominal surgery at Umeå university hospital. Excluded are patients with American Society of Anesthesia (ASA) class 2-3 and patients with cognitive impairment or dementia, unable to participate. Patients with ongoing CPAP treatment are not randomized. Instead, they form a separate group with ongoing CPAP after surgery
The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery.
Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery.
PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP.
All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery.
A need of 35 patients in each arm was estimated to detect a difference in mean (SD) in PaO2 of 1 (1.5) kilo Pascal with a significance of p<0.05 and a power of 80%. Due to dropouts, it is estimated a need to include and randomize 120 patients.
Patients in the CPAP treated group are given an auto-CPAP that can increase the pressure during respiratory arrest (AirSense 10 AutoSet, ResMed Inc) including a silicone nasal mask. It is set with a minimum pressure of 5 cm and a maximum pressure of 10 cm during instruction on the day before surgery. Pressure and mask are tested by trained personnel at the Lung section so that both pressure and mask are comfortable and can be tolerated by the patient. Immediately after surgery they will be given CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%.
Patients in the control group receive standard treatment and supplemental oxygen if oxygen saturation falls below 90%
Included in a third arm are patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. They are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.
- Being tested
- Auto-CPAP, CPAP since before
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-CPAPDevice
AIrSense 10, Auto-CPAP, Minimum pressure 5 cm water, maximum pressure 10 cm water
CPAP since beforeDevice
A CPAP the patient uses since before because of previously diagnosed obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Regular treatment |
| Auto CPAP | Experimental | Auto CPAP, AirSense 10 AutoSet, ResMed Inc, max pressure 10 cm water, min pressure 5 cm water Receives: Device: Auto-CPAP |
| CPAP since before | Other | Patients with CPAP since before will all continue using CPAP. They will not attend the randomization process. They will be regarded as a separate group. Receives: Device: CPAP since before |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen partial pressure
Difference in PaO2
Measured: Difference in change from baseline before surgery to follow-up at postoperative day 2
Secondary outcomes (8)
Diffusion capacity for carbon monoxide
Difference in diffusion capacity
Measured: Difference in change from baseline before surgery to follow-up at postoperative day 2
Forced vital capacity (FVC)
Difference in FVC
Measured: Difference in change from baseline before surgery to follow-up at postoperative day 2
Forced expiratory volume in one second (FEV1)
Difference in FEV1
Measured: Difference in change from baseline before surgery to follow-up at postoperative day 2
PaCO2
Difference in PaCO2
Measured: Difference in change from baseline before surgery to follow-up at postoperative day 2
time of hypoxia with SaO2 <90%
Time with hypoxia (SaO2 <90%)
Measured: During postoperative night 2
Side effects of CPAP
Type of side effects from CPAP
Measured: From day of surgery to the second postoperative day
CPAP compliance
Number of hours using CPAP
Measured: From day of surgery to the second postoperative day
Sleep apnea
Effect of CPAP with regard to the occurrence of sleep apnea
Measured: From day of surgery to the second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start10 May 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- Karl A Franklin, Prof, Principal investigator, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747535
- Sponsor's protocol ID
- 2020-03408
- Status last verified
- Mar 2021
- First submitted
- 7 Feb 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure After Abdominal Surgery -A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04747535
- Acronym / sponsor ID
- 2020-03408
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2021 (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.
This is a randomized controlled trial with an allocation ratio of 1:1. Half the patients are randomized to continuous positive airway pressure (CPAP) and half to routine medical care. Included are one hundred and twenty patients aged 18-80 years plus patients with ongoing CPAP scheduled for abdominal surgery at Umeå university hospital. The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery. Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery. PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP. All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery.
Patients in the CPAP treated group are given an auto-CPAP with a minimum pressure of 5 cm and a maximum pressure of 10 cm. They will be treated with CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%. Patients in the control group receives standard treatment and supplemental oxygen if oxygen saturation falls below 90%. In a third arm, we will include patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.
Detailed description
Theory Research question: Does nasal CPAP abolish postoperative hypoxia and lung function decline after abdominal surgery?
Methods This is a randomized controlled trial with an allocation ratio of 1:1. Half of the patients are randomized to CPAP and half to routine medical care. Randomization is generated by a computer program and handled by a person outside the study. Randomization procedure is documented by the contact person and in the patient's study protocol.
Include are one hundred and twenty patients age 18-80 years old, scheduled for abdominal surgery at Umeå university hospital. Excluded are patients with American Society of Anesthesia (ASA) class 2-3 and patients with cognitive impairment or dementia, unable to participate. Patients with ongoing CPAP treatment are not randomized. Instead, they form a separate group with ongoing CPAP after surgery
The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery.
Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery.
PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP.
All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery.
A need of 35 patients in each arm was estimated to detect a difference in mean (SD) in PaO2 of 1 (1.5) kilo Pascal with a significance of p<0.05 and a power of 80%. Due to dropouts, it is estimated a need to include and randomize 120 patients.
Patients in the CPAP treated group are given an auto-CPAP that can increase the pressure during respiratory arrest (AirSense 10 AutoSet, ResMed Inc) including a silicone nasal mask. It is set with a minimum pressure of 5 cm and a maximum pressure of 10 cm during instruction on the day before surgery. Pressure and mask are tested by trained personnel at the Lung section so that both pressure and mask are comfortable and can be tolerated by the patient. Immediately after surgery they will be given CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%.
Patients in the control group receive standard treatment and supplemental oxygen if oxygen saturation falls below 90%
Included in a third arm are patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. They are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Regular treatment |
| Auto CPAP | Experimental | Device: Auto-CPAPAuto CPAP, AirSense 10 AutoSet, ResMed Inc, max pressure 10 cm water, min pressure 5 cm water |
| CPAP since before | Other | Device: CPAP since beforePatients with CPAP since before will all continue using CPAP. They will not attend the randomization process. They will be regarded as a separate group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (age 18-80 years) scheduled for elective abdominal surgery
- Must be able to tolerate nasal CPAP
Key exclusion criteria (2 listed)
- American Society Anesthesia (ASA) Class 3-4.
- Cognitive impairment or dementia
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 |
|---|---|---|
| Auto-CPAPAIrSense 10, Auto-CPAP, Minimum pressure 5 cm water, maximum pressure 10 cm water | Device | Auto CPAP |
| CPAP since beforeA CPAP the patient uses since before because of previously diagnosed obstructive sleep apnea | Device | CPAP since before |
Primary outcome
Arterial oxygen partial pressure
Time frame: Difference in change from baseline before surgery to follow-up at postoperative day 2
Difference in PaO2
8 secondary outcomes
Diffusion capacity for carbon monoxide
Time frame: Difference in change from baseline before surgery to follow-up at postoperative day 2
Forced vital capacity (FVC)
Time frame: Difference in change from baseline before surgery to follow-up at postoperative day 2
Forced expiratory volume in one second (FEV1)
Time frame: Difference in change from baseline before surgery to follow-up at postoperative day 2
PaCO2
Time frame: Difference in change from baseline before surgery to follow-up at postoperative day 2
time of hypoxia with SaO2 <90%
Time frame: During postoperative night 2
Side effects of CPAP
Time frame: From day of surgery to the second postoperative day
CPAP compliance
Time frame: From day of surgery to the second postoperative day
Sleep apnea
Time frame: From day of surgery to the second postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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, Prof principal investigator
Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-CPAP and CPAP since before in people with Abdominal Surgery and Continuous Positive Airway Pressure, 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 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: status not confirmed, as of the sponsor's last update on 30 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl A Franklin, Prof (+46 706884745, karl.franklin@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen partial pressure (time frame: Difference in change from baseline before surgery to follow-up at postoperative day 2). 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 30 Apr 2021.