Driving Pressure in Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-19

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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After screened for preoperative risk factors, 48 patients undergoing elective laparoscopic surgery 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 pneumoperitoneum and position adjustment by increasing PEEP from 5 to 15 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 as COV (center of ventilation) is the primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a trained technician who is blinded to randomization. Arterial blood gas is tested, with inflammatory and oxidative mediators from venous sample. Postoperative pulmonary complications within 3 days are also recorded.

Conditions

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Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional PEEP

PEEP = 5 cmH2O

Group Type PLACEBO_COMPARATOR

PEEP

Intervention Type PROCEDURE

different PEEP set on the anesthetic machine

Driving pressure (DP) guided-PEEP

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.

Group Type EXPERIMENTAL

PEEP

Intervention Type PROCEDURE

different PEEP set on the anesthetic machine

Interventions

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PEEP

different PEEP set on the anesthetic machine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No