Titration of Intraoperative PEEP in Patients Undergoing Robotic Assisted Laparoscopic Prostatectomy

NCT05155371 | Completed

• 1 other identifier: PEEP Titration of RALP
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

Optimal intraoperative positive end expiratory pressure (PEEP) improves the outcome. Optimal PEEP is not only very different among individuals, but each individual's optimal PEEP is affected by positioning, muscle paralysis, and several other factors. Several techniques have been used to determine the optimal PEEP. For example, electrical impedance tomography(EIT)can be performed at the bedside.However, the application of this technique requires special training, increases the workload of the care team, and the cost-efficiencyof this procedure remains to be determined.We hypothesized that optimal PEEP could be obtained by titration of intraoperative PEEP levels and FiO2with SpO2 guidance. Our secondary hypothesis was that maintenance of intraoperative optimal PEEP derived via this method improves intraoperative oxygenation and reduces the incidence of postoperative hypoxemia.We tested our hypothesis in patients undergoing robotic-assisted laparoscopic prostatectomy.

Conditions

Positive End Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

• The difference of optimal PEEP titrated by two methods

  Titration result of the two groups

  within 30 minutes after trachea intubation

Secondary Outcomes (4)

• Difference of intraoperative PaO2/FiO2 between the two groups

  30,60,120 minutes after finishing PEEP titration

• Difference of intraoperative driving pressure, dynamic compliance between the two groups

  30,60,120 minutes after finishing PEEP titration

• Difference of lung regional ventilation between the two groups

  5 minutes after trachea extubation

• Post operation hypoxemia in PACU.

  within 30 minutes after trachea extubation

Study Arms (2)

Optimal Positive End-expiratory Pressure obtained with Titration of Fraction of Inspiratory Oxygen

EXPERIMENTAL

Obtained Optimal Positive End-expiratory Pressure obtained with Titration of Fraction of Inspiratory Oxygen and sustained the PEEP intraoperatively

Other: Titration of Optimal Positive End-expiratory Pressure

Optimal Positive End-expiratory Pressure obtained with electrical impedance tomography

EXPERIMENTAL

Obtained Optimal Positive End-expiratory Pressure obtained with EIT and sustained the PEEP intraoperatively

Other: Titration of Optimal Positive End-expiratory Pressure

Interventions

Titration of Optimal Positive End-expiratory Pressure OTHER

Titration of Optimal Positive End-expiratory Pressure with two different methods

Optimal Positive End-expiratory Pressure obtained with Titration of Fraction of Inspiratory Oxygen; Optimal Positive End-expiratory Pressure obtained with electrical impedance tomography

Eligibility Criteria

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

You may qualify if:

• adult patients aged 18 years or older
• scheduled for elective robotic-assisted laparoscopic prostatectomy(RALP)
• ASA physical status of I-III

You may not qualify if:

• acute or chronic respiratory disorders
• pulmonary hypertension
• neuromuscular disease
• preoperative SpO2\<95% on room air

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Study Officials

• Jun Zhang, PhD

  Department of Anesthesiology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 13, 2021
• Study Start: October 20, 2021
• Primary Completion: December 8, 2022
• Study Completion: January 20, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)