- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421976
Driving Pressure in Neurosurgery (DPNS)
July 1, 2021 updated by: Wei Zhang, Capital Medical University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100070
- Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Progressive neuromuscular illness
- Pregnancy
- Refusal to participate
- Contradicted to EIT scan or lung ultrasound scan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Conventional PEEP
PEEP = 5 cmH2O
|
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.
|
Experimental: Driving pressure (DP) guided-PEEP
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately after extubation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Melbourne Group Scale version 2 (MGS-2)
Time Frame: within the first 3 days after surgery
|
Melbourne Group Scale version 2 (MGS-2): Temperature >38°C; White cell count >11.2 or use of respiratory antibiotics; Physician diagnosis of pneumonia or chest infection; Chest X-ray findings of atelectasis/consolidation; Production of purulent (yellow/green) sputum different from preoperative sputum; Positive results upon sputum microbiological analysis; oxygen saturation by pulse oximetry (SpO2)<90% in ambient air; Re-admission to or prolonged stay (>36 h) in the intensive care unit/high dependency unit for respiratory problems.
A postoperative pulmonary complication (PPC) was diagnosed if 4 or more of the 8 factors were present.
|
within the first 3 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ruquan Han, MD,PHD, Beijing Tiantan Hospital affiliated with Capital Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2020
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
May 29, 2020
First Submitted That Met QC Criteria
June 4, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 6, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- DP-Neurosurgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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