Influence of Inspiratory Pause on Ventilatory Efficiency in Robotic Surgery. A Prospective Paired Study.

NCT05514366 | Completed

• 1 other identifier: EIP2022.FISEVI
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to determine if the modification of the end inspiratory pause (EIP) during mechanical ventilation adds benefit when applied to patients undergoing robotic surgery and who are ventilated under an individualized open lung approach (iOLA) strategy. The EIP is an adjustable parameter of volume controlled ventilation modes usually set as a percentage of the total inspiratory time. It represents the phase comprised between the moment in which the volume programmed in the ventilator has already been administered (which marks the end of the inspiratory flow), and the opening of the expiratory valve (which marks the beginning of expiration). The investigators will study whether modifications of the EIP produce variations in the "quantity" of the lung that participates in gas exchange (respiratory volume). To do so, the investigators will sequentially apply different EIP to participants (paired study). The investigators´ hypothesis is that increasing the EIP up to a level, may diminish the lung volume that does not participate in breathing (the physiological dead space- VDphys), thereby increasing the respiratory volume. To note: the VDphys includes the "conduction" volume, that represented by trachea, bronchi, et cetera, which is in charge of driving the "air" towards the respiratory zones, and the alveolar dead space (those zones of the respiratory volume that due to different reasons do not directly participate in gas exchange: alveoli ventilated but not perfused, areas of overdistension, etc. The investigators will measure dead volumes by mean of specific non-invasive monitoring (volumetric capnography) coupled to the anesthesia workstation, and the mechanics of lung and the distribution of the gas within it by means of electric impedance tomography, a non-invasive technique showing continuous images of patient's lung. The estimation of the respiratory volume will help the investigators to more precisely adjust the amount of oxygen and anesthetic gases that must be administered in function of patients´ gases consumption, a calculated parameter that is function of the respiratory volume and that will also be tested during the study. The investigators will also accurately measure patient oxygenation by means of arterial blood samples extracted from a radial artery catheter. Apart from sequential modifications in the EIP, the ventilation strategy applied to patients will be that used in the investigators´ usual practice (described below).

Conditions

Mechanical Ventilation; Positive End-Expiratory Pressure; Anesthesia

Keywords

Intermittent Positive-Pressure Ventilation; Positive End-Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

• Changes in physiological dead space volume (VDphys)

  VDphys is that percentage of the tidal volume not participating of gas exchange

  Through the study completion: assessed in moments 1, 2, 3, 5, 7a and 8

Secondary Outcomes (2)

• Changes in intra-tidal gas distribution

  Through the study completion: assessed in moments 1, 2, 3, 5, 7a and 8

• Changes in arterial partial pressure of oxygen

  Through the study completion: assessed in moments 1, 3, 7b and 8

Study Arms (1)

End inspiratory pause under tOLA

EXPERIMENTAL

Application of four different end inspiratory pauses (EIP) corresponding to 10, 20, 30 and 40% of inspiratory time. Phase 1) before the application of pneumoperitoneum and forced trendelenburg. Phase 2) during the application of pneumoperitoneum and forced trendelenburg. During both phases, all patients will be ventilated under a tOLA strategy (see Study Description section).

Procedure: Modifying EIP under a tOLA before pneumoperitoneum; Procedure: Modifying EIP under a tOLA with pneumoperitoneum; Procedure: Atelectasis test

Interventions

Modifying EIP under a tOLA before pneumoperitoneum PROCEDURE

Phase 1: Moment (M) 1) Standard PPV and an initial EIP of 10% M 2) ARM with titration of optimal PEEP (PEEPop) on a decremental PEEP trial, followed by a new ARM and setting a tailored open-lung PEEP (tOL-PEEP), that 2 cm H2O higher than PEEPop M 3) Incremental modification of the EIP in steps of 10% (from 10 to 40%)

End inspiratory pause under tOLA

Modifying EIP under a tOLA with pneumoperitoneum PROCEDURE

Phase 2: M 4) The investigators will apply the EIP that guarantees the lowest Pdriv M 5) After applying pneumoperitoneum and trendelenburg M 6) Atelectasis test (see below) M 7) M 7a) In case of atelectasis test = negative: the investigators will modify the EIP in incremental or decremental steps of 10% M 7b) In case of atelectasis test=positive: ARM M 8) In those cases recruited (M 7b), modify the EIP (as in M 7a) Once the EIP that guarantees the best ventilation conditions has been stablished based on the lowest Pdriv (and higher Crs), the investigators will maintain these conditions until the end of surgery, with periodic evaluation of the pulmonary collapse by means of the atelectasis test (see below) performed every 40 minutes or regardless of time if an oxygen saturation by pulse oximetry (SpO2) \< 97% is detected.

End inspiratory pause under tOLA

Atelectasis test PROCEDURE

It is performed during mechanical ventilation, due to suspicion of alveolar collapse. Alveolar collapse will be suspected on observation of a reduction in Crs \> 10% over post-recruitment values. In these cases the atelectasis test will be performed, consisting of a reduction in FiO2 to 0.21, maintaining this FiO2 for 5 minutes. If lung collapse is \>10%, a fall in SpO2 below 97% will be expected (positive atelectasis test), in which case, an ARM and a PEEPop titration test will be performed.

End inspiratory pause under tOLA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (≥ 18 years) scheduled for robotic prostatic surgery at the investigators´ institution
• Written informed consent

You may not qualify if:

• Participation in another interventional study
• Participants unable to understand the information contained in the informed consent
• American Society of Anesthesiologists (ASA) classification grade = IV
• Patient in dialysis
• Chronic obstructive pulmonary disease (COPD) grade Global Initiative for Chronic Obstructive Lung Disease(GOLD) \> 2
• Functional vital capacity \< 60% or \> 120% of the predicted
• Body mass index (BMI) \> 35 kg/m2
• Relation PaO2/FiO2 \<200 mmHg in the baseline sample
• Presence of mechanical ventilation in the 72 hours prior to enrollment
• New York Heart Association (NYHA) functional class ≥ 3
• Clinically suspected heart failure
• Diagnosis or suspicion of intracranial hypertension
• Presence of pneumothorax or giant bullae on preoperative imaging tests
• Use of Continuous Positive Airway Pressure (CPAP).

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (23)

• Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.

  PMID: 26174419 BACKGROUND

• Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.

  PMID: 23385321 BACKGROUND

• Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13.

  PMID: 25466352 BACKGROUND

• Futier E, Constantin JM, Jaber S. Protective lung ventilation in operating room: a systematic review. Minerva Anestesiol. 2014 Jun;80(6):726-35. Epub 2013 Nov 13.

  PMID: 24226493 BACKGROUND

• Guay J, Ochroch EA. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in patients without acute lung injury. Cochrane Database Syst Rev. 2015 Dec 7;(12):CD011151. doi: 10.1002/14651858.CD011151.pub2.

  PMID: 26641378 BACKGROUND

• Wolthuis EK, Choi G, Dessing MC, Bresser P, Lutter R, Dzoljic M, van der Poll T, Vroom MB, Hollmann M, Schultz MJ. Mechanical ventilation with lower tidal volumes and positive end-expiratory pressure prevents pulmonary inflammation in patients without preexisting lung injury. Anesthesiology. 2008 Jan;108(1):46-54. doi: 10.1097/01.anes.0000296068.80921.10.

  PMID: 18156881 BACKGROUND

• Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

  PMID: 23093163 BACKGROUND

• Petrucci N, De Feo C. Lung protective ventilation strategy for the acute respiratory distress syndrome. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD003844. doi: 10.1002/14651858.CD003844.pub4.

  PMID: 23450544 BACKGROUND

• Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017.

  PMID: 28493943 BACKGROUND

• Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1.

  PMID: 25927183 BACKGROUND

• Ferrando C, Aldecoa C, Unzueta C, Belda FJ, Librero J, Tusman G, Suarez-Sipmann F, Peiro S, Pozo N, Brunelli A, Garutti I, Gallego C, Rodriguez A, Garcia JI, Diaz-Cambronero O, Balust J, Redondo FJ, de la Matta M, Gallego-Ligorit L, Hernandez J, Martinez P, Perez A, Leal S, Alday E, Monedero P, Gonzalez R, Mazzirani G, Aguilar G, Lopez-Baamonde M, Felipe M, Mugarra A, Torrente J, Valencia L, Varon V, Sanchez S, Rodriguez B, Martin A, India I, Azparren G, Molina R, Villar J, Soro M; iPROVE-O2 Network. Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):110-120. doi: 10.1016/j.bja.2019.10.009. Epub 2019 Nov 22.

  PMID: 31767144 BACKGROUND

• Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.

  PMID: 24557111 BACKGROUND

• Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.

  PMID: 29371130 BACKGROUND

• Maisch S, Reissmann H, Fuellekrug B, Weismann D, Rutkowski T, Tusman G, Bohm SH. Compliance and dead space fraction indicate an optimal level of positive end-expiratory pressure after recruitment in anesthetized patients. Anesth Analg. 2008 Jan;106(1):175-81, table of contents. doi: 10.1213/01.ane.0000287684.74505.49.

  PMID: 18165575 BACKGROUND

• Williams EC, Motta-Ribeiro GC, Vidal Melo MF. Driving Pressure and Transpulmonary Pressure: How Do We Guide Safe Mechanical Ventilation? Anesthesiology. 2019 Jul;131(1):155-163. doi: 10.1097/ALN.0000000000002731.

  PMID: 31094753 BACKGROUND

• Aboab J, Niklason L, Uttman L, Kouatchet A, Brochard L, Jonson B. CO2 elimination at varying inspiratory pause in acute lung injury. Clin Physiol Funct Imaging. 2007 Jan;27(1):2-6. doi: 10.1111/j.1475-097X.2007.00699.x.

  PMID: 17204030 BACKGROUND

• Aboab J, Niklason L, Uttman L, Brochard L, Jonson B. Dead space and CO(2) elimination related to pattern of inspiratory gas delivery in ARDS patients. Crit Care. 2012 Dec 12;16(2):R39. doi: 10.1186/cc11232.

  PMID: 22390777 BACKGROUND

• Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.

  PMID: 27558174 BACKGROUND

• Devaquet J, Jonson B, Niklason L, Si Larbi AG, Uttman L, Aboab J, Brochard L. Effects of inspiratory pause on CO2 elimination and arterial PCO2 in acute lung injury. J Appl Physiol (1985). 2008 Dec;105(6):1944-9. doi: 10.1152/japplphysiol.90682.2008. Epub 2008 Sep 18.

  PMID: 18801962 BACKGROUND

• Uttman L, Jonson B. A prolonged postinspiratory pause enhances CO2 elimination by reducing airway dead space. Clin Physiol Funct Imaging. 2003 Sep;23(5):252-6. doi: 10.1046/j.1475-097x.2003.00498.x.

  PMID: 12950321 BACKGROUND

• Sturesson LW, Malmkvist G, Allvin S, Collryd M, Bodelsson M, Jonson B. An appropriate inspiratory flow pattern can enhance CO2 exchange, facilitating protective ventilation of healthy lungs. Br J Anaesth. 2016 Aug;117(2):243-9. doi: 10.1093/bja/aew194.

  PMID: 27440637 BACKGROUND

• Lopez-Herrera D, De La Matta M. Influence of the end inspiratory pause on respiratory mechanics and tidal gas distribution of surgical patients ventilated under a tailored open lung approach strategy: A randomised, crossover trial. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101038. doi: 10.1016/j.accpm.2022.101038. Epub 2022 Feb 17.

  PMID: 35183806 BACKGROUND

• Tusman G, Acosta CM, Ochoa M, Bohm SH, Gogniat E, Martinez Arca J, Scandurra A, Madorno M, Ferrando C, Suarez Sipmann F. Multimodal non-invasive monitoring to apply an open lung approach strategy in morbidly obese patients during bariatric surgery. J Clin Monit Comput. 2020 Oct;34(5):1015-1024. doi: 10.1007/s10877-019-00405-w. Epub 2019 Oct 25.

  PMID: 31654282 BACKGROUND

Study Officials

• Manuel de la Matta, MD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: February 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After finishing data analysis
• Access Criteria: Upon other researchers request, through mail contact with the principal researcher

Locations

ES (1)