NeurosurgeryDPNSNCT04421976
Driving Pressure in Neurosurgery
A study testing PEEP in people with Neurosurgery, run by Capital Medical University at 1 site in China.
Trial summary
The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery. Patients are recruited to receive volume controlled ventilation with either a fixed PEEP (5cmH2O) or DP titrated PEEP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neurosurgery
- What is being tested?
- PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2020to 1 Jul 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent has been obtained
- Elective neurosurgery
- Expected ventilation duration > 2 hours
- Scheduled to be extubated in the operation
- American Society of Anesthesiologists (ASA) physical status >2
Who cannot join
- Mechanical ventilation of > 1 hour within the last 2 weeks before surgery
- Dysphagia resulting from preoperative cranial nerve damage
- Body mass index ≥ 35 kg/m2
- Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome)
- Emergency surgery
- Severe cardiac disease
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- Progressive neuromuscular illness
- Pregnancy
- Refusal to participate
- Contradicted to EIT scan or lung ultrasound scan
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Driving Pressure for Early Postoperative Redistribution of Pulmonary Ventilation in Neurosurgery : A Prospective Randomized Controlled Trial
The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery. Patients are recruited to receive volume controlled ventilation with either a fixed PEEP (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation, expressed as global inhomogeneity (GI) is evaluated by electrical impedance tomography (EIT), a noninvasive, radiation free modality. Center of ventilation (COV) by EIT, as well as the lung ultrasonography（LUS), perioperative ventilatory parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary outcome variables.
Read the detailed description
After screened for preoperative risk factors, 44 patients undergoing elective neurosurgery and planned to be extubated in the operating room are randomly assigned to two groups: (1) PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol consists of volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General Electric Company Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted body weight (PBW), fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (arterial carbon dioxide partial pressure between 35 and 45 mmHg). For group 2, trial for the lowest DP was started 10 min after position adjustment by increasing PEEP from 2 to 10 cm H2O incrementally. DP was calculated as "plateau pressure - PEEP". Each PEEP level was maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP was identified and maintained intraoperatively. A plateau pressure of no more than 30 cmH2O is targeted in each group. Early postoperative distribution of regional ventilation global inhomogeneity (GI) is the primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a trained technician who is blinded to randomization. Center of ventilation (COV) by EIT, lung ultrasonography（LUS) , and arterial blood gas are evaluated, with inflammatory and oxidative mediators tested from venous sample. Brain relaxation will be scored by the neurosurgeon. Postoperative pulmonary complications within 3 days are also recorded.
- Conditions
- Neurosurgery
- Being tested
- PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPProcedure or surgery
Driving pressure (DP) is calculated as "plateau pressure - PEEP". 10min after position adjustment, PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Conventional PEEP | Placebo comparator | PEEP = 5 cmH2O Receives: Procedure: PEEP |
| Driving pressure (DP) guided-PEEP | Experimental | PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively. Receives: Procedure: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative overall spatial distribution of pulmonary ventilation
global inhomogeneity index (GI): overall degree of spatial heterogeneity of ventilation. GI is measured by electrical impedance tomography (EIT). A smaller GI index represents a more homogeneous distribution, and a larger GI index indicates a more inhomogeneous ventilation.
Measured: immediately after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start21 Jun 2020
- Primary completion1 Apr 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeurosurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Capital Medical University
- Investigators
- Ruquan Han, MD,PHD, Study director, Beijing Tiantan Hospital affiliated with Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421976
- Sponsor's protocol ID
- DP-Neurosurgery
- Acronym
- DPNS
- Status last verified
- Jul 2021
- First submitted
- 29 May 2020
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu F, Zhang W, Zhao Z, Xu X, Jian M, Han R. Effect of driving pressure on early postoperative lung gas distribution in supratentorial craniotomy: a randomized controlled trial. BMC Anesthesiol. 2023 May 22;23(1):176. doi: 10.1186/s12871-023-02144-7.
PubMed 37217882
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure for Early Postoperative Redistribution of Pulmonary Ventilation in Neurosurgery : A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04421976
- Acronym / sponsor ID
- DPNS / DP-Neurosurgery
- Conditions
- Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 21 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Jun 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.
The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery. Patients are recruited to receive volume controlled ventilation with either a fixed PEEP (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation, expressed as global inhomogeneity (GI) is evaluated by electrical impedance tomography (EIT), a noninvasive, radiation free modality. Center of ventilation (COV) by EIT, as well as the lung ultrasonography（LUS), perioperative ventilatory parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary outcome variables.
Detailed description
After screened for preoperative risk factors, 44 patients undergoing elective neurosurgery and planned to be extubated in the operating room are randomly assigned to two groups: (1) PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol consists of volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General Electric Company Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted body weight (PBW), fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (arterial carbon dioxide partial pressure between 35 and 45 mmHg). For group 2, trial for the lowest DP was started 10 min after position adjustment by increasing PEEP from 2 to 10 cm H2O incrementally. DP was calculated as "plateau pressure - PEEP". Each PEEP level was maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP was identified and maintained intraoperatively. A plateau pressure of no more than 30 cmH2O is targeted in each group. Early postoperative distribution of regional ventilation global inhomogeneity (GI) is the primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a trained technician who is blinded to randomization. Center of ventilation (COV) by EIT, lung ultrasonography（LUS) , and arterial blood gas are evaluated, with inflammatory and oxidative mediators tested from venous sample. Brain relaxation will be scored by the neurosurgeon. Postoperative pulmonary complications within 3 days are also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional PEEP | Placebo comparator | Procedure: PEEPPEEP = 5 cmH2O |
| Driving pressure (DP) guided-PEEP | Experimental | Procedure: PEEPPEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent has been obtained
- Elective neurosurgery
- Expected ventilation duration > 2 hours
- Scheduled to be extubated in the operation
- American Society of Anesthesiologists (ASA) physical status >2
Key exclusion criteria (10 listed)
- Mechanical ventilation of > 1 hour within the last 2 weeks before surgery
- Dysphagia resulting from preoperative cranial nerve damage
- Body mass index ≥ 35 kg/m2
- Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome)
- Emergency surgery
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 |
|---|---|---|
| PEEPDriving pressure (DP) is calculated as "plateau pressure - PEEP". 10min after position adjustment, PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively. | Procedure or surgery | Conventional PEEP, Driving pressure (DP) guided-PEEP |
Primary outcome
early postoperative overall spatial distribution of pulmonary ventilation
Time frame: immediately after extubation
global inhomogeneity index (GI): overall degree of spatial heterogeneity of ventilation. GI is measured by electrical impedance tomography (EIT). A smaller GI index represents a more homogeneous distribution, and a larger GI index indicates a more inhomogeneous ventilation.
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 6 Jul 2021.
- Derived from this study: PubMed 37217882Liu F, Zhang W, Zhao Z, Xu X, Jian M, Han R. Effect of driving pressure on early postoperative lung gas distribution in supratentorial craniotomy: a randomized controlled trial. BMC Anesthesiol. 2023 May 22;23(1):176. doi: 10.1186/s12871-023-02144-7.
- 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.
Ruquan Han, MD,PHD study director
Beijing Tiantan Hospital affiliated with Capital Medical 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 PEEP in people with Neurosurgery, run by Capital Medical 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 5 inclusion and 10 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 6 Jul 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 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. Some participants in this study may receive a placebo. 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?
early postoperative overall spatial distribution of pulmonary ventilation (time frame: immediately after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421976, which also lists 1 linked publication.
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 6 Jul 2021.