Driving Pressure in Laparoscopic Surgery

NCT04374162 | Completed

• 1 other identifier: DP-Laparoscopy
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 laparoscopic surgery. 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 center of ventilation (COV) is evaluated by electrical impedance tomography (EIT), a noninvasive, radiation free modality. Perioperative ventilatory parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary outcome variables.

Conditions

Laparoscopy

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)

• incidence of postoperative pulmonary complications (PPCs)

  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

DP is calculated as "plateau pressure - PEEP". 10 min after pneumoperitoneum， PEEP is increased from 5 to 15 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

PEEP PROCEDURE

different PEEP set on the anesthetic machine

Conventional PEEP; Driving pressure (DP) guided-PEEP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been obtained
• Elective laparoscopic surgery with Trendelenburg position
• Expected ventilation duration \> 2 hours
• Scheduled to be extubated in the operation

You may not qualify if:

• Mechanical ventilation of \> 1 hour within the last 2 weeks before surgery
• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• Zhang W, Liu F, Zhao Z, Shao C, Xu X, Ma J, Han R. Driving pressure-guided ventilation improves homogeneity in lung gas distribution for gynecological laparoscopy: a randomized controlled trial. Sci Rep. 2022 Dec 15;12(1):21687. doi: 10.1038/s41598-022-26144-8.

  PMID: 36522433 DERIVED

Study Officials

• Ruquan Han, MD,PHD

  Beijing Tiantan Hospital

  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: April 26, 2020
• First Posted: May 5, 2020
• Study Start: May 19, 2020
• Primary Completion: February 24, 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)