Perioperative ComplicationNCT04728945
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery
A study testing lung recruitment and Standard ventilatory management in people with Perioperative Complication and Hypoxia, run by Osaka University at 1 site in Japan.
Trial summary
Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication, Hypoxia
- What is being tested?
- lung recruitment and Standard ventilatory management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- 18 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours
Who cannot join
- Lateral or supine position
- BMI > 35
- One-second rate <70%, %VC <80%, obstructive, restrictive, with bra
- Cardiovascular disease (NYHA III or higher)
- Intracranial hypertensive disease
- Emergency surgery
Show all 9Show fewer
- Pregnancy
- Glaucoma
- Patients judged unsuitable by the anesthesiologist in charge
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Suita, Osaka, 565-0871
Yuji Fujino, MD., Ph.D., +81-6-6879-5820, fujino@anes.med.osaka-u.ac.jp
About this study
Official title: Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.
Read the detailed description
The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.
- Conditions
- Perioperative Complication, Hypoxia
- Being tested
- lung recruitment, Standard ventilatory management
- Keywords
- perioperative pulmonary complications, lung recruitment, laparoscopic surgery
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitmentProcedure or surgery
Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
Standard ventilatory managementProcedure or surgery
After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary.
[initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)
| Study group | Role | What they receive |
|---|---|---|
| lung recruitment | Experimental | Standard ventilatory management with lung recruitment every 30 minutes Receives: Procedure: lung recruitment; Procedure: Standard ventilatory management |
| control | Active comparator | Standard ventilatory management Receives: Procedure: Standard ventilatory management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia
SpO2 less than 95% or more than 2% decrease from baseline
Measured: During laparoscopy procedure
Time to onset of hypoxia
Duration from the start of laparoscopic surgery to the onset of hypoxia
Measured: During laparoscopy procedure
Secondary outcomes (7)
Rate of decrease in SpO2
Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery
Measured: During laparoscopy procedure
Ventilator setting at the end of surgery
Ventilator settings such as FIO2, PEEP, and plateau pressure
Measured: During surgery
compliance rate of lung recruitment
compliance rate of lung recruitment in the intevention group
Measured: During laparoscopy procedure
Safety endpoint: Circulatory agonist use
Circulatory agonist use
Measured: During surgery
Safety endpoint: total fluid infusion
total fluid infusion
Measured: During surgery
Safety endpoint: incidence of complications
incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator)
Measured: During surgery
Postoperative hypoxia
Presence of hypoxia the day after surgery
Measured: the day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start18 Jun 2021
- Primary completion28 Feb 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 Perioperative ComplicationStudies 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
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Toho University
- Responsible party
- Sponsor
- Investigators
- Yuji Fujino, Study chair, Department of Anesthesiology and Intensive Care Medicine, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728945
- Sponsor's protocol ID
- Reclap study
- Status last verified
- Aug 2021
- First submitted
- 25 Jan 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
- ClinicalTrials.gov ID
- NCT04728945
- Acronym / sponsor ID
- Reclap study
- Conditions
- Perioperative Complication, Hypoxia
- Keywords
- perioperative pulmonary complications, lung recruitment, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Toho University
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jan 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.
Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.
Detailed description
The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung recruitment | Experimental | Procedure: lung recruitment, Procedure: Standard ventilatory managementStandard ventilatory management with lung recruitment every 30 minutes |
| control | Active comparator | Procedure: Standard ventilatory managementStandard ventilatory management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours
Key exclusion criteria (9 listed)
- Lateral or supine position
- BMI > 35
- One-second rate <70%, %VC <80%, obstructive, restrictive, with bra
- Cardiovascular disease (NYHA III or higher)
- Intracranial hypertensive disease
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 |
|---|---|---|
| lung recruitmentAutomatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy. | Procedure or surgery | lung recruitment |
| Standard ventilatory managementAfter tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary. [initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW) | Procedure or surgery | control, lung recruitment |
Primary outcome
Incidence of hypoxia
Time frame: During laparoscopy procedure
SpO2 less than 95% or more than 2% decrease from baseline
Time to onset of hypoxia
Time frame: During laparoscopy procedure
Duration from the start of laparoscopic surgery to the onset of hypoxia
7 secondary outcomes
Rate of decrease in SpO2
Time frame: During laparoscopy procedure
Ventilator setting at the end of surgery
Time frame: During surgery
compliance rate of lung recruitment
Time frame: During laparoscopy procedure
Safety endpoint: Circulatory agonist use
Time frame: During surgery
Safety endpoint: total fluid infusion
Time frame: During surgery
Safety endpoint: incidence of complications
Time frame: During surgery
Postoperative hypoxia
Time frame: the day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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.
Yuji Fujino study chair
Department of Anesthesiology and Intensive Care Medicine, Osaka 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 lung recruitment and Standard ventilatory management in people with Perioperative Complication and Hypoxia, run by Osaka University at 1 site in Japan.
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 9 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 Aug 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 Japan. 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 Yuji Fujino, MD., Ph.D. (+81-6-6879-5820, fujino@anes.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (time frame: During laparoscopy procedure). The study lists 2 primary outcomes in all. 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 Aug 2021.