NCT04421976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

June 21, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

May 29, 2020

Last Update Submit

July 1, 2021

Conditions

Neurosurgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately after extubation

Other Outcomes (1)

  • Melbourne Group Scale version 2 (MGS-2)

    within the first 3 days after surgery

Study Arms (2)

Conventional PEEP

PLACEBO COMPARATOR

PEEP = 5 cmH2O

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.

Procedure: PEEP

Interventions

PEEPPROCEDURE

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.

Conventional PEEPDriving pressure (DP) guided-PEEP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

  • 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.

    PMID: 37217882DERIVED

Study Officials

  • Ruquan Han, MD,PHD

    Beijing Tiantan Hospital affiliated with Capital Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 9, 2020

Study Start

June 21, 2020

Primary Completion

April 1, 2021

Study Completion

July 1, 2021

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)