Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries

Atelectasis, Postoperative Pulmonary Clinical Trial

Official title:

The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327193
• Other study ID #: SYoon_DP_RALP
• Status: Completed
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: October 6, 2020

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position

Exclusion Criteria:

• American Society of Anesthesiologists physical status IV or more

• Severe cardiovascular disease

• Severe chronic obstructive pulmonary disease, emphysema

• History of pneumothorax, bullae

• History of lung resection surgery

• Conversion to laparotomy

• Refusal to participate

Related Conditions & MeSH terms

• Atelectasis, Postoperative Pulmonary
• Pulmonary Atelectasis

Intervention

Procedure:
• Titrated PEEP based on driving pressure
Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.
• Conventional PEEP
Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongnogu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified lung ultrasound score	The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.	30 minutes after PACU administration
Secondary	Modified lung ultrasound score	The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.	Intraoperative (at the end of operation before emergence)
Secondary	Incidence of intraoperative desaturation	Oxygen saturation by pulse oximetry< 95%	Intraoperative
Secondary	Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Intraoperative (30 minutes after designated PEEP applied)
Secondary	Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio	30 minutes after PACU administration
Secondary	Postoperative pulmonary complications	Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia	After operation~ postoperative day 3