Anesthesia, GeneralPEEP-RMNCT03083457
Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation
A study testing Fluid resuscitation or amine administration, General anesthetic and Fluid administration in people with Anesthesia, General and Surgery, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General, Surgery
- What is being tested?
- Fluid resuscitation or amine administration, General anesthetic and Fluid administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2017to 30 Nov 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
- ASA physical status I-II patients
- scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery)
- Expected duration of surgery >= 150 minutes
Who cannot join
- Pregnancy
- BMI>30 kg/m^2
- hepatic surgery
- Cardiac failure NYHA>2
- History of chronic respiratory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Effects of Positive End-expiratory Pressure With or Without Recruiting Maneuvers in Patients Receiving Low-tidal Volume Ventilation During General Anesthesia for Open Abdominal Surgery. A Randomized, Cross-over Study
Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.
A recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established.
Read more
Design: prospective, cross-over, physiological trial.
PURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.
- Conditions
- Anesthesia, General, Surgery
- Being tested
- Fluid resuscitation or amine administration, General anesthetic, Fluid administration, Low-tidal volume ventilation, Scheduled recruiting maneuvers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid resuscitation or amine administrationDrug
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anestheticDrug
Total intravenous anesthesia with a standard protocol
Fluid administrationDrug
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilationProcedure or surgery
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
Scheduled recruiting maneuversProcedure or surgery
Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP
| Study group | Role | What they receive |
|---|---|---|
| PEEP2 + RM | Experimental | General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study Receives: Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation; Procedure: Scheduled recruiting maneuvers |
| PEEP7 + RM | Experimental | General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study Receives: Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation; Procedure: Scheduled recruiting maneuvers |
| PEEP12 + RM | Experimental | General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study Receives: Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation; Procedure: Scheduled recruiting maneuvers |
| PEEP2 - RM | Experimental | General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study Receives: Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation |
| PEEP7 - RM | Experimental | General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study Receives: Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation |
| PEEP12 - RM. | Experimental | General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study Receives: Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Pressure
Respiratory system elastic pressure (Plateau pressure-total PEEP)
Measured: At the end of each 40-minute step
Secondary outcomes (14)
Lung strain
Lung static and dynamic strain
Measured: At the end of each 40-minute step
Dead space
Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
Measured: At the end of each 40-minute step
Oxygenation
PaO2/FiO2
Measured: At the end of each 40-minute step
Lung recruitment
% (lung recruitment/change in end-expiratory lung volume)
Measured: At the end of each 40-minute step
Lung overdistension due to PEEP
% (lung overdistension/change in end-expiratory lung volume)
Measured: At the end of each 40-minute step
Functional residual capacity
Change in functional residual capacity due to PEEP, measured with the Nitrogen washin-washout technique
Measured: At the end of each 40-minute step
Heart rate
heart rate
Measured: At the end of each 40-minute step
Blood pressure
Arterial blood pressure
Measured: At the end of each 40-minute step
Stroke volume
Stroke volume, measured by pulse contour analysis
Measured: At the end of each 40-minute step
Stroke volume variation
Stroke volume variation, measured by pulse contour analysis
Measured: At the end of each 40-minute step
Cardiac Output
Stroke volume x heart rate
Measured: At the end of each 40-minute step
Fluid requirements
Fluid bolus requirements, according to the decision of the attending physician blinded to the design of the study
Measured: At the end of each 40-minute step
Vasoactive agents
Vasoactive agents requirements, according to the decision of the attending physician blinded to the design of the study
Measured: At the end of each 40-minute step
Adverse events
Adverse events
Measured: At the end of each 40-minute step
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start20 Mar 2017
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will be randomized to receive or not scheduled recruiting maneuvers every hour. In each of the two groups, patients will receive mechanical ventilation with 3 different levels of PEEP in a sequential, randomized, cross-over manner: each period will last 40 minutes. A randomization sequence will be produced by a dedicated software and sealed envelopes will be used to allocate patients to study treatments.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Antonelli, Catholic University of the Sacred Heart
- Investigators
- Massimo Antonelli, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083457
- Sponsor's protocol ID
- 10989/15
- Acronym
- PEEP-RM
- Status last verified
- Jan 2021
- First submitted
- 14 Mar 2017
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Positive End-expiratory Pressure With or Without Recruiting Maneuvers in Patients Receiving Low-tidal Volume Ventilation During General Anesthesia for Open Abdominal Surgery. A Randomized, Cross-over Study
- ClinicalTrials.gov ID
- NCT03083457
- Acronym / sponsor ID
- PEEP-RM / 10989/15
- Conditions
- Anesthesia, General, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 20 Mar 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.
Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.
A recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established.
Design: prospective, cross-over, physiological trial.
PURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Each patient will be randomized to receive or not scheduled recruiting maneuvers every hour. In each of the two groups, patients will receive mechanical ventilation with 3 different levels of PEEP in a sequential, randomized, cross-over manner: each period will last 40 minutes. A randomization sequence will be produced by a dedicated software and sealed envelopes will be used to allocate patients to study treatments.
| Arm | Type | Receives |
|---|---|---|
| PEEP2 + RM | Experimental | Drug: Fluid resuscitation or amine administration, Drug: General anesthetic, Drug: Fluid administration, Procedure: Low-tidal volume ventilation, Procedure: Scheduled recruiting maneuversGeneral anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study |
| PEEP7 + RM | Experimental | Drug: Fluid resuscitation or amine administration, Drug: General anesthetic, Drug: Fluid administration, Procedure: Low-tidal volume ventilation, Procedure: Scheduled recruiting maneuversGeneral anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study |
| PEEP12 + RM | Experimental | Drug: Fluid resuscitation or amine administration, Drug: General anesthetic, Drug: Fluid administration, Procedure: Low-tidal volume ventilation, Procedure: Scheduled recruiting maneuversGeneral anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study |
| PEEP2 - RM | Experimental | Drug: Fluid resuscitation or amine administration, Drug: General anesthetic, Drug: Fluid administration, Procedure: Low-tidal volume ventilationGeneral anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study |
| PEEP7 - RM | Experimental | Drug: Fluid resuscitation or amine administration, Drug: General anesthetic, Drug: Fluid administration, Procedure: Low-tidal volume ventilationGeneral anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study |
| PEEP12 - RM. | Experimental | Drug: Fluid resuscitation or amine administration, Drug: General anesthetic, Drug: Fluid administration, Procedure: Low-tidal volume ventilationGeneral anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-II patients
- scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery)
- Expected duration of surgery >= 150 minutes
Key exclusion criteria (5 listed)
- Pregnancy
- BMI>30 kg/m^2
- hepatic surgery
- Cardiac failure NYHA>2
- History of chronic respiratory failure
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 |
|---|---|---|
| Fluid resuscitation or amine administrationFluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis | Drug | PEEP12 + RM, PEEP12 - RM., PEEP2 + RM, PEEP2 - RM, PEEP7 + RM, PEEP7 - RM |
| General anestheticTotal intravenous anesthesia with a standard protocol | Drug | PEEP12 + RM, PEEP12 - RM., PEEP2 + RM, PEEP2 - RM, PEEP7 + RM, PEEP7 - RM |
| Fluid administration3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure | Drug | PEEP12 + RM, PEEP12 - RM., PEEP2 + RM, PEEP2 - RM, PEEP7 + RM, PEEP7 - RM |
| Low-tidal volume ventilationVolume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study | Procedure or surgery | PEEP12 + RM, PEEP12 - RM., PEEP2 + RM, PEEP2 - RM, PEEP7 + RM, PEEP7 - RM |
| Scheduled recruiting maneuversPressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP | Procedure or surgery | PEEP12 + RM, PEEP2 + RM, PEEP7 + RM |
Primary outcome
Driving Pressure
Time frame: At the end of each 40-minute step
Respiratory system elastic pressure (Plateau pressure-total PEEP)
14 secondary outcomes
Lung strain
Time frame: At the end of each 40-minute step
Dead space
Time frame: At the end of each 40-minute step
Oxygenation
Time frame: At the end of each 40-minute step
Lung recruitment
Time frame: At the end of each 40-minute step
Lung overdistension due to PEEP
Time frame: At the end of each 40-minute step
Functional residual capacity
Time frame: At the end of each 40-minute step
Heart rate
Time frame: At the end of each 40-minute step
Blood pressure
Time frame: At the end of each 40-minute step
Stroke volume
Time frame: At the end of each 40-minute step
Stroke volume variation
Time frame: At the end of each 40-minute step
Cardiac Output
Time frame: At the end of each 40-minute step
Fluid requirements
Time frame: At the end of each 40-minute step
Vasoactive agents
Time frame: At the end of each 40-minute step
Adverse events
Time frame: At the end of each 40-minute step
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 29 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Massimo Antonelli, MD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid resuscitation or amine administration, General anesthetic and Fluid administration in people with Anesthesia, General and Surgery, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 inclusion and 5 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 29 Jan 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 Italy. 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?
Driving Pressure (time frame: At the end of each 40-minute step). 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 29 Jan 2021.