Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery

NCT03435913 | Completed

• 1 other identifier: 2016/0602
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled with different ventilatory positive end-expiratory pressure levels affects the transpulmonary driving pressure during pneumoperiteneum insufflation for laparoscopic surgery. Methodology: Patients undergoing laparoscopic surgery will be included. The study will investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary driving pressure (TpDp) and the effect of titration of PEEP on their relationship. At three different levels of intra-abdominal pressure, the respiratory driving pressure (RDp) and TpDp in each subject will be measured in each subject. The same subject will undergo two different ventilation strategies. Demographic data (height, weight, body mass index and sex), ASA physical status (surgical risk classification of the American Society of Anesthesiology), number of previous abdominal surgeries, number of previous pregnancies, and respiratory comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables recorded will include: airway pressures (Plateau pressure Pplat, Peak pressure, Ppeak), the final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed linear regression will be used to evaluate the relationship between different PEEP levels, IAP and TpDp by adjusting for known confounders and adding individuals as a random factor. Likewise, an analysis using a mixed linear regression model with the pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime, and a specific random intercept term for each subject will be performed.

Conditions

Anesthesia, General/Methods; Laparoscopy; Respiration, Artificial; Positive-Pressure Respiration; End-Expiratory Pressure, Positive; Ventilator-Induced Lung Injury

Keywords

Mechanical ventilation; Driving Pressure; Protective Lung VEntilation

Outcome Measures

Primary Outcomes (1)

• Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation

  TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure

  Pneumoperitoneum insufflation before surgery (up to 30 minutes)

Secondary Outcomes (6)

• Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)

  Pneumoperitoneum insufflation before surgery (up to 30 minutes)

• Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).

  Pneumoperitoneum insufflation before surgery (up to 30 minutes)

• Respiratory system compliance (Crs) difference between standard and matched PEEP levels

  Pneumoperitoneum insufflation before surgery (up to 30 minutes)

• Pulmonary compliance (Cp) difference

  Pneumoperitoneum insufflation before surgery (up to 30 minutes)

• Chest wall compliance (CCw) difference

  Pneumoperitoneum insufflation before surgery (up to 30 minutes)

Study Arms (2)

Standard PEEP ventilation

EXPERIMENTAL

During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and 5 cmH20 of PEEP at every intra-abdominal pressure (IAP) step (8, 12 and 15 mmHg).

Other: Standard PEEP ventilation; Other: Matched PEEP ventilation

Matched PEEP Ventilation

EXPERIMENTAL

During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and a level of PEEP matched to every IAP step (8, 12 and 15 mmHg). 1 mmHg = 1,36 cmH20. Between the standard and matched PEEP intervention there is a washout period that with a recruitment maneuver to re-establish baseline lung condition.

Other: Standard PEEP ventilation; Other: Matched PEEP ventilation

Interventions

Standard PEEP ventilation OTHER

During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation

Matched PEEP Ventilation; Standard PEEP ventilation

Matched PEEP ventilation OTHER

During mechanical ventilation PEEP is matched to IAP level

Matched PEEP Ventilation; Standard PEEP ventilation

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiology (ASA) risk scale I to III
• Age \> 18 years
• Previously signed informed consent
• Undergoing laparoscopic surgery

You may not qualify if:

• ASA ≥ IV
• Pregnancy
• Advanced liver, kidney or cardiopulmonary disease

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitario La Fe

Valencia, Spain

Location

Related Publications (4)

• 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

• Cortes-Puentes GA, Gard KE, Adams AB, Faltesek KA, Anderson CP, Dries DJ, Marini JJ. Value and limitations of transpulmonary pressure calculations during intra-abdominal hypertension. Crit Care Med. 2013 Aug;41(8):1870-7. doi: 10.1097/CCM.0b013e31828a3bea.

  PMID: 23863222 BACKGROUND

• Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.

  PMID: 23196259 BACKGROUND

• D'Antini D, Rauseo M, Grasso S, Mirabella L, Camporota L, Cotoia A, Spadaro S, Fersini A, Petta R, Menga R, Sciusco A, Dambrosio M, Cinnella G. Physiological effects of the open lung approach during laparoscopic cholecystectomy: focus on driving pressure. Minerva Anestesiol. 2018 Feb;84(2):159-167. doi: 10.23736/S0375-9393.17.12042-0. Epub 2017 Jul 5.

  PMID: 28679201 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Consultant

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 19, 2018
• Study Start: April 19, 2018
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)