Influence of the End-inspiratory Pause on Mechanical Ventilation.

NCT03568786 | Completed DMC

• 1 other identifier: 1172-M1-16
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the influence of two different end-inspiratory pause (EIP) times on respiratory mechanics and arterial gases of surgical patients when ventilated under an open lung approach (OLA) strategy. The investigators evaluate the impact of using EIP 10% versus 30% of the inspiratory time on a volume control model. The investigators also analyse the potential influence of these EIP on pulmonary gas distribution measured by electric impedance tomography.

Conditions

Anesthesia; Surgery

Keywords

end-inspiratory pause; lung protection; intraoperative ventilation; lung compliance

Outcome Measures

Primary Outcomes (1)

• Changes in Respiratory System Compliance (ml/cmH2O)

  Measurement of the respiratory system compliance (Crs; ml/cmH2O) when using an EIP of 10% versus 30% of the global inspiratory time.

  Moment 0 (M0): 5 minutes (min) after tracheal intubation, with volume control and PEEP of 5 cmH2O; M1: 5 min after alveolar recruitment maneuver (ARM); M2: 5 min after crossing time of EIP; M3: 5 min after new ARM; M4: 5 min after crossing time EIP

Secondary Outcomes (1)

• Changes in Driving Pressure (Pdriv; cmH2O)

  Moment 0 (M0): 5 minutes (min) after tracheal intubation, with volume control and PEEP of 5 cmH2O; M1: 5 min after alveolar recruitment maneuver (ARM); M2: 5 min after crossing time of EIP; M3: 5 min after new ARM; M4: 5 min after crossing time EIP

Study Arms (2)

End-inspiratory pause (EIP) 10%

EXPERIMENTAL

Once the patient is intubated and after initiating ventilation in a volume control mode using a tidal volume of 7 ml/kg of predicted body weight (PBW) with an inspiration: expiration ratio of 1:2; a respiratory rate of 12-14 breaths per minute to maintain the etCO2 at 35-40 mmHg and an initial PEEP of 5 cmH2O, the investigators will apply an alveolar recruitment maneuver (ARM) with estimation of the open lung PEEP using an end-inspiratory pause (EIP) corresponding with a of 10% of the total inspiratory time. Volume control ventilation will be restored after ARM maintaining the same ventilatory parameters except the EIP, which in this group will be of 10% of total inspiratory time.

Procedure: End-inspiratory pause 10%

End-inspiratory pause (EIP) 30%

EXPERIMENTAL

Once the patient is intubated and after initiating ventilation in a volume control mode using a tidal volume of 7 ml/kg of predicted body weight (PBW) with an inspiration: expiration ratio of 1:2; a respiratory rate of 12-14 breaths per minute to maintain the etCO2 at 35-40 mmHg and an initial PEEP of 5 cmH2O, the investigators will apply an alveolar recruitment maneuver (ARM) with estimation of the open lung PEEP using an end-inspiratory pause (EIP) corresponding with a 30 % of the total inspiratory time. Volume control ventilation will be restored after ARM maintaining the same ventilatory parameters except the EIP, which in this group will be of 30 % of total inspiratory time.

Procedure: End-inspiratory pause 30%

Interventions

End-inspiratory pause 10% PROCEDURE

Percentage of the total inspiratory time in which there is no gas flow. It is the period of time between the cessation of the inspiratory flow and the start of expiration. In this intervention arm it would correspond to a 10% of the total inspiratory time

Also known as: Time of inspiratory pause 10%

End-inspiratory pause (EIP) 10%

End-inspiratory pause 30% PROCEDURE

Percentage of the total inspiratory time in which there is no gas flow. It is the period of time between the cessation of the inspiratory flow and the start of expiration. In this intervention arm it would correspond to a 30% of the total inspiratory time

Also known as: Time of inspiratory pause 30%

End-inspiratory pause (EIP) 30%

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years proposed for major abdominal surgery under general anesthesia.
• Written informed consent.

You may not qualify if:

• Participation in another interventional study
• American Society of Anesthesiologists (ASA) classification grade = IV
• Patient in dialysis
• Chronic obstructive pulmonary disease (COPD) grade GOLD (Global Initiative for Chronic Obstructive Lung Disease) \> 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
• Cardiac Index (IC) \< 2.5 ml/min/m2 and/or inotropics prior to surgery
• 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)

Fundación Pública Andaluza para la Gestión de Investigación de Salud en Sevilla

Seville, 41013, Spain

Location

Related Publications (18)

• 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

• PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.

  PMID: 24894577 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

• Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

  PMID: 26947624 BACKGROUND

• Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

  PMID: 25693014 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

• 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

• 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

• 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

• Pillet O, Choukroun ML, Castaing Y. Effects of inspiratory flow rate alterations on gas exchange during mechanical ventilation in normal lungs. Efficiency of end-inspiratory pause. Chest. 1993 Apr;103(4):1161-5. doi: 10.1378/chest.103.4.1161.

  PMID: 8131458 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

• Fuleihan SF, Wilson RS, Pontoppidan H. Effect of mechanical ventilation with end-inspiratory pause on blood-gas exchange. Anesth Analg. 1976 Jan-Feb;55(1):122-30. doi: 10.1213/00000539-197601000-00034.

  PMID: 942823 BACKGROUND

• Astrom E, Uttman L, Niklason L, Aboab J, Brochard L, Jonson B. Pattern of inspiratory gas delivery affects CO2 elimination in health and after acute lung injury. Intensive Care Med. 2008 Feb;34(2):377-84. doi: 10.1007/s00134-007-0840-7. Epub 2007 Sep 1.

  PMID: 17763841 BACKGROUND

• Suter PM, Jevic MG, Hemmer M, Gemperle M. [The effects of the pause at the end of inspiration on gas exchange and hemodynamics during artificial ventilation]. Can Anaesth Soc J. 1977 Sep;24(5):550-8. doi: 10.1007/BF03005528. French.

  PMID: 332285 BACKGROUND

• Bardoczky GI, d'Hollander AA, Rocmans P, Estenne M, Yernault JC. Respiratory mechanics and gas exchange during one-lung ventilation for thoracic surgery: the effects of end-inspiratory pause in stable COPD patients. J Cardiothorac Vasc Anesth. 1998 Apr;12(2):137-41. doi: 10.1016/s1053-0770(98)90319-6.

  PMID: 9583541 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

• Taskar V, John J, Larsson A, Wetterberg T, Jonson B. Dynamics of carbon dioxide elimination following ventilator resetting. Chest. 1995 Jul;108(1):196-202. doi: 10.1378/chest.108.1.196.

  PMID: 7606958 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 DERIVED

Study Officials

• Daniel López-Herrera

  Fundación Pública Andaluza para la Investigación de Salud en Sevilla (FISEVI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: June 26, 2018
• Study Start: November 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: July 30, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication.and with no end date.
• Access Criteria: Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal. Proposals should be directed to Dr Daniel López-Herrera; e mail address: dalohero@gmail.com. To gain access, data requestors will need to sign a data Access agreement.

Locations

ES (1)