Mechanical PowerREMAIN-2NCT05962125
The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation
A study testing periodic alveolar recruitment maneuvers and positive end-expiratory pressure in people with Mechanical Power and Alveolar Recruitment Maneuvers, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mechanical Power, Alveolar Recruitment Maneuvers, Protective Ventilation
- What is being tested?
- periodic alveolar recruitment maneuvers and positive end-expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2023to 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
- Had an intermediate risk of developing postoperative pulmonary complications.
- Pulse oxygen saturation in room air ≥ 94%.
- Aged 60 to 80 years.
Who cannot join
- 1. Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.
- 2. Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV or higher.
- 6. Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: Effects of Three Open-lung Strategies on Respiratory Function and Lung Injury in Protective Ventilation for Laparoscopic Anterior Resection: a Randomized Controlled Trial
The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.
- Conditions
- Mechanical Power, Alveolar Recruitment Maneuvers, Protective Ventilation, Postoperative Pulmonary Complications
- Being tested
- periodic alveolar recruitment maneuvers, positive end-expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodic alveolar recruitment maneuversOther
A stepwise increment of tidal volume was used for each ARM.
positive end-expiratory pressureOther
a PEEP of 6 to 8 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| periodic alveolar recruitment maneuvers (PARM) alone | Experimental | Alveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. Receives: Other: periodic alveolar recruitment maneuvers |
| positive end-expiratory pressure (PEEP) alone | Active comparator | PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O. Receives: Other: positive end-expiratory pressure |
| a combination of PEEP and PARM | Active comparator | Alveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O. Receives: Other: periodic alveolar recruitment maneuvers; Other: positive end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative mechanical power
Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat])
Measured: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Secondary outcomes (23)
Mechanical power during capnoperitoneum
mechanical power, J/min
Measured: 30 minutes after starting carbon dioxide pneumoperitoneum
Accumulative mechanical power (AMP)
Accumulative mechanical power (AMP) = AMP before capnoperitoneum + AMP during capnoperitoneum + AMP after capnoperitoneum. Accumulative mechanical power before capnoperitoneum = mechanical power before capnoperitoneum (10 min after mechanical ventilation) × the length of mechanical ventilation before capnoperitoneum. Accumulative mechanical power during capnoperitoneum = mechanical power during capnoperitoneum (30 min after mechanical ventilation) × the length of mechanical ventilation during capnoperitoneum. Accumulative mechanical power after capnoperitoneum (after the end of capnoperitoneum) = mechanical power after capnoperitoneum (10 min after the end of capnoperitoneum) × the length of mechanical ventilation after capnoperitoneum
Measured: During intraoperative mechanical ventilation, an average of 3 hours
An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)
P/F ratio, mmHg
Measured: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Shunt fraction
Shunt fraction, %
Measured: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Dead space rate
Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.
Measured: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Rate of respiratory failure at post-anesthesia care unit (PACU)
Respiratory failure: PaO2 < 60 mmHg or pulse oxygen saturation (SpO2) < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.
Measured: Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU
Soluble advanced glycation end products receptor (sRAGE)
The concentration of plasma sRAGE, pg/ml
Measured: 20 minutes after entering PACU
Clara cell protein 16 (CC16)
The concentration of plasma CC16, ng/ml
Measured: 20 minutes after entering PACU
Surfactant Protein D (SP-D)
The concentration of plasma SP-D, ug/ml
Measured: 20 minutes after entering PACU
Interleukin 6 (IL-6)
The concentration of plasma IL-6, pg/ml
Measured: 20 minutes after entering PACU
Rate of postoperative respiratory failure
Respiratory failure: PaO2 < 60 mmHg or SpO2 < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.
Measured: Time Frame: Day 0 to 3 after surgery
Rate of sustained hypoxaemia
Sustained hypoxaemia, hypoxaemia at any two consecutive days; hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5%.
Measured: Day 0 to 3 after surgery
Postoperative pulmonary complications score
Postoperative pulmonary complications score: Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).
Measured: Day 0 to 3 after surgery
Postoperative hospitalization days
The duration between the operation date and the actual discharge date.
Measured: Day 0 to 30 after surgery
Death from any cause
Intraoperative or postoperative death from any cause
Measured: Day 0 to 30 after surgery
Rate of intraoperative hypotension
Intraoperative hypotension, mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes.
Measured: During intraoperative mechanical ventilation, an average of 3 hours
Rate of need for vasoconstrictors
MAP < 60 mmHg and using any vasoconstrictors.
Measured: During intraoperative mechanical ventilation, an average of 3 hours
Rate of intraoperative hypoxemia
Intraoperative hypoxemia, SpO2 ≤ 92% lasting more than 3 minutes.
Measured: During intraoperative mechanical ventilation, an average of 3 hours
Rate of intraoperative bradycardia
Intraoperative bradycardia, heart rate ≤ 50 bpm and the decrease of heart rate from the basic value ≥ 20% lasting more than 3 minutes.
Measured: During intraoperative mechanical ventilation, an average of 3 hours
Rate of pneumothorax
Pneumothorax, air in the pleural space with no vascular bed surrounding the visceral pleura.
Measured: During surgery or within 7 days after surgery
Rate of pleural effusion
Pleural effusion, diagnosed according to previous literature (Doi: 10.1097/EJA.0000000000000118).
Measured: within 7 days after surgery
Unexpected admission to ICU
It does not include the patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness.
Measured: within 30 days after surgery
Tumor Necrosis Factor alpha (TNF-α)
TNF-α, pg/ml.
Measured: 20 minutes after entering PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start21 Aug 2023
- Primary completion8 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical PowerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Li, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962125
- Sponsor's protocol ID
- E2023069
- Acronym
- REMAIN-2
- Status last verified
- Sep 2023
- First submitted
- 28 Jun 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Open-lung Strategies on Respiratory Function and Lung Injury in Protective Ventilation for Laparoscopic Anterior Resection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05962125
- Acronym / sponsor ID
- REMAIN-2 / E2023069
- Conditions
- Mechanical Power, Alveolar Recruitment Maneuvers, Protective Ventilation, Postoperative Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jul 2023 (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.
The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodic alveolar recruitment maneuvers (PARM) alone | Experimental | Other: periodic alveolar recruitment maneuversAlveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. |
| positive end-expiratory pressure (PEEP) alone | Active comparator | Other: positive end-expiratory pressurePEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O. |
| a combination of PEEP and PARM | Active comparator | Other: periodic alveolar recruitment maneuvers, Other: positive end-expiratory pressureAlveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
- Had an intermediate risk of developing postoperative pulmonary complications.
- Pulse oxygen saturation in room air ≥ 94%.
- Aged 60 to 80 years.
Key exclusion criteria (3 listed)
- 1. Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.
- 2. Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV or higher.
- 6. Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.
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 |
|---|---|---|
| periodic alveolar recruitment maneuversA stepwise increment of tidal volume was used for each ARM. | Other | a combination of PEEP and PARM, periodic alveolar recruitment maneuvers (PARM) alone |
| positive end-expiratory pressurea PEEP of 6 to 8 cm H2O | Other | a combination of PEEP and PARM, positive end-expiratory pressure (PEEP) alone |
Primary outcome
Intraoperative mechanical power
Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat])
23 secondary outcomes
Mechanical power during capnoperitoneum
Time frame: 30 minutes after starting carbon dioxide pneumoperitoneum
Accumulative mechanical power (AMP)
Time frame: During intraoperative mechanical ventilation, an average of 3 hours
An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)
Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Shunt fraction
Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Dead space rate
Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Rate of respiratory failure at post-anesthesia care unit (PACU)
Time frame: Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU
Soluble advanced glycation end products receptor (sRAGE)
Time frame: 20 minutes after entering PACU
Clara cell protein 16 (CC16)
Time frame: 20 minutes after entering PACU
Surfactant Protein D (SP-D)
Time frame: 20 minutes after entering PACU
Interleukin 6 (IL-6)
Time frame: 20 minutes after entering PACU
Rate of postoperative respiratory failure
Time frame: Time Frame: Day 0 to 3 after surgery
Rate of sustained hypoxaemia
Time frame: Day 0 to 3 after surgery
Postoperative pulmonary complications score
Time frame: Day 0 to 3 after surgery
Postoperative hospitalization days
Time frame: Day 0 to 30 after surgery
Death from any cause
Time frame: Day 0 to 30 after surgery
Rate of intraoperative hypotension
Time frame: During intraoperative mechanical ventilation, an average of 3 hours
Rate of need for vasoconstrictors
Time frame: During intraoperative mechanical ventilation, an average of 3 hours
Rate of intraoperative hypoxemia
Time frame: During intraoperative mechanical ventilation, an average of 3 hours
Rate of intraoperative bradycardia
Time frame: During intraoperative mechanical ventilation, an average of 3 hours
Rate of pneumothorax
Time frame: During surgery or within 7 days after surgery
Rate of pleural effusion
Time frame: within 7 days after surgery
Unexpected admission to ICU
Time frame: within 30 days after surgery
Tumor Necrosis Factor alpha (TNF-α)
Time frame: 20 minutes after entering PACU
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 3 Dec 2024.
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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.
Hong Li, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen 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 periodic alveolar recruitment maneuvers and positive end-expiratory pressure in people with Mechanical Power and Alveolar Recruitment Maneuvers, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 4 inclusion and 3 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 3 Dec 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 China. 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?
Intraoperative mechanical power (time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of 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 3 Dec 2024.