Driving Pressure in Neurosurgery

NCT ID: NCT04421976

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-21
• Study Completion Date: 2021-07-01

Brief 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. 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.

Conditions

Neurosurgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Conventional PEEP

PEEP = 5 cmH2O

Group Type: PLACEBO_COMPARATOR

PEEP

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

PEEP

Intervention Type: PROCEDURE

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.

Interventions

PEEP

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruquan Han, MD,PHD

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital affiliated with Capital Medical University

Locations

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37217882 (View on PubMed)

Other Identifiers

DP-Neurosurgery

Identifier Type: -

Identifier Source: org_study_id