Comparison of Three Methods of PEEP Titration During One Lung Ventilation in Prone Position

NCT05851612 | Completed

• 1 other identifier: PEEP in OLV in prone position
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

One-lung ventilation and prone positioning during thoracoscopic esophagectomy is associated with pulmonary complications so lung protection is strongly recommended. Individualization the optimal PEEP level according to the respira¬tory condition of patients has gradually attracted the attention of clinicians. The aim of this study is to compare and evaluate the differences between three different PEEP values in patients who will undergo thoracoscopic esophagectomy receiving either constant PEEP or driving pressure guided individualized PEEP or oxygenation guided individualized PEEP.

Conditions

One Lung Ventilation

Keywords

optimal PEEP -one lung ventilation-prone position

Outcome Measures

Primary Outcomes (1)

• lung ultrasound score

  Thorax will be divided into 12 segments. The lung ultrasound score is 0 to 3, based on the B-line count and the degree of subpleural solidity. A total score of 0-36 will be obtained by summing the scores of the 12 segments. The absolute difference in the three lung ultrasound scores measured before induction, before neuromuscular block reversal, at the end of surgery/before extubation, and 5 min before leaving the PACU respectively.

  Up to 5 min before leaving the post anesthesia care unit (PACU)

Secondary Outcomes (23)

• Positive end-expiratory pressure (PEEP)

  Up to the end of the procedure

• The ratio of partial pressure of oxygen in arterial blood to the fraction of inspiratory oxygen concentration (PaO2/FiO2 ratio)

  Up to the end of the procedure

• Heart rate (HR)

  Up to the end of the procedure

• The Central venous pressure (CVP) values

  Up to the end of the procedure

• The total volume of fluids and vasopressors administered

  Up to the end of the procedure

Study Arms (3)

group C(constant group)

ACTIVE COMPARATOR

Constant PEEP of 5 centimeter of water (cm H2O) will be applied

Procedure: constant PEEP

group D (driving group)

ACTIVE COMPARATOR

PEEP titration will be according to driving pressure

Procedure: Driving pressure guided PEEP

group O (oxygenation group)

ACTIVE COMPARATOR

PEEP titration will be according to oxygenation method

Procedure: oxygenation method guided PEEP

Interventions

constant PEEP PROCEDURE

Constant PEEP of 5 cm H2O will be applied and maintained throughout one-lung ventilation.

group C(constant group)

Driving pressure guided PEEP PROCEDURE

PEEP titration will be started at 5 cmH2O and then increased in 1 cmH2O interval to 10 cmH2O. After 10 breath cycles will maintained, Driving pressure (ΔP) will be measured at each PEEP level at the last cycle. The PEEP indicating the lowest ΔP will be selected if multiple levels of PEEP showed the same lowest ΔP, the lowest PEEP will be selected. Driving pressure will be calculated as plateau pressure minus PEEP. Titration will stopped if peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension will be observed.

group D (driving group)

oxygenation method guided PEEP PROCEDURE

PEEP titration will be started from 5 cmH2O and increase of 1 cmH2O every 4 min with fixed driving pressure that will result in delivery of a fixed tidal volume (TV) of 6ml/kg ideal body weight (IBW). Optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected.

group O (oxygenation group)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) (grade 1or 2) patients.
• Scheduled for elective thoracoscopic esophagectomy treated with one lung ventilation in prone position and surgery of expected duration greater than 1 h.
• Body mass index (BMI) less than 30 kg/m2.

You may not qualify if:

• Patient's refusal.
• Altered mental status or un-cooperative patients.
• History of known sensitivity to the used anesthetics.
• Significant cardiac dysfunction, hepatic, or renal impairment.
• History of severe chronic obstructive pulmonary disease.
• History of severe or uncontrolled bronchial asthma.
• History of severe restrictive lung disease.
• History of pulmonary metastases.
• History of any thoracic surgery.
• Need for chest drainage prior to surgery.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (7)

• Choi YS, Shim JK, Na S, Hong SB, Hong YW, Oh YJ. Pressure-controlled versus volume-controlled ventilation during one-lung ventilation in the prone position for robot-assisted esophagectomy. Surg Endosc. 2009 Oct;23(10):2286-91. doi: 10.1007/s00464-008-0310-5. Epub 2009 Jan 30.

  PMID: 19184209 RESULT

• Wang ZY, Ye SS, Fan Y, Shi CY, Wu HF, Miao CH, Zhou D. Individualized positive end-expiratory pressure with and without recruitment maneuvers in obese patients during bariatric surgery. Kaohsiung J Med Sci. 2022 Sep;38(9):858-868. doi: 10.1002/kjm2.12576. Epub 2022 Jul 22.

  PMID: 35866347 RESULT

• Park M, Ahn HJ, Kim JA, Yang M, Heo BY, Choi JW, Kim YR, Lee SH, Jeong H, Choi SJ, Song IS. Driving Pressure during Thoracic Surgery: A Randomized Clinical Trial. Anesthesiology. 2019 Mar;130(3):385-393. doi: 10.1097/ALN.0000000000002600.

  PMID: 30664548 RESULT

• Yao W, Yang B, Wang W, Han Q, Liu F, Shan S, Wang C, Zheng M. Effect of Positive End-Expiratory Pressure (PEEP) Titration in Elderly Patients Undergoing Lobectomy. Med Sci Monit. 2022 Dec 13;28:e938225. doi: 10.12659/MSM.938225.

  PMID: 36510453 RESULT

• Liu K, Huang C, Xu M, Wu J, Frerichs I, Moeller K, Zhao Z. PEEP guided by electrical impedance tomography during one-lung ventilation in elderly patients undergoing thoracoscopic surgery. Ann Transl Med. 2019 Dec;7(23):757. doi: 10.21037/atm.2019.11.95.

  PMID: 32042773 RESULT

• Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

  PMID: 27669555 RESULT

• Xu Q, Guo X, Liu J, Li SX, Ma HR, Wang FX, Lin JY. Effects of dynamic individualized PEEP guided by driving pressure in laparoscopic surgery on postoperative atelectasis in elderly patients: a prospective randomized controlled trial. BMC Anesthesiol. 2022 Mar 16;22(1):72. doi: 10.1186/s12871-022-01613-9.

  PMID: 35296253 RESULT

Study Officials

• Amany EL-Deeb, MD

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation and set up the ventilator as specified in the envelope. The study subjects and the resident assessing the outcome will be blinded to the study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 9, 2023
• Study Start: June 5, 2023
• Primary Completion: October 10, 2024
• Study Completion: November 21, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

EG (1)