Lung-protective Mechanical Ventilation for Abdominal Laparoscopic Surgeries

NCT04546932 | Completed DMC

• 1 other identifier: VMMU20193
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This was a double-blind, randomized controlled clinical trial. 62 patients were randomly assigned to receive either lung-protective ventilation (LPV) with a tidal volume (Vt) of 7 ml/kg ideal body weight (IBW), 10 cmH2O positive end-expiratory pressure (PEEP) combined with regular recruitment maneuvers or conventional ventilation (CV) with a Vt of 10 ml/kg IBW, 0 cmH2O in PEEP and no recruitment maneuvers. The primary endpoints were the intraoperative fluctuation of Cdyn and Cstat, the intra- and postoperative changes in pulmonary oxygenation function including OI, A-aO2. The secondary endpoints were the alteration on chest x-ray, modified Clinical Pulmonary Infection Score (mCPIS), and the incidence of PPCs on the first postoperative day

Conditions

Mechanical Ventilation Complication

Keywords

Lung-protective mechanical ventilation; Low tidal volume; Positive end-expiratory pressure; Recruitment maneuvers

Outcome Measures

Primary Outcomes (4)

• Changes in intraoperative pulmonary dynamic compliance

  At a specific time point, the dynamic compliance (Cdyn in ml/cmH2O) was measured directly on the ventilator. Changes in Cdyn were recorded at H0 (after intubation), H1 (30 minutes after pneumoperitoneum), H2 (1 hour after pneumoperitoneum), H3 (2 hours after pneumoperitoneum), Hkt (10 minutes after pneumoperitoneum stopped) and Hro (before extubation).

  H0 (after intubation), H1 (30 minutes after pneumoperitoneum), H2 (1 hour after pneumoperitoneum), H3 (2 hours after pneumoperitoneum), Hkt (10 minutes after pneumoperitoneum stopped) and Hro (before extubation)

• Changes in intraoperative pulmonary static compliance

  At a specific time point, the static compliance (Cstat in ml/cmH2O)) was calculated in accordance with the pre-defined formula as Vt (ml)/\[plateau pressure of the respiratory system (cmH2O) - PEEP(cmH2O)\] with the plateau pressure was measured during the normal ventilation setting using an inspiratory pause at 10% of the inspiratory time. Changes in Cstat were recorded at H0 (after intubation), H1 (30 minutes after pneumoperitoneum), H2 (1 hour after pneumoperitoneum), H3 (2 hours after pneumoperitoneum), Hkt (10 minutes after pneumoperitoneum stopped) and Hro (before extubation)

  H0 (after intubation), H1 (30 minutes after pneumoperitoneum), H2 (1 hour after pneumoperitoneum), H3 (2 hours after pneumoperitoneum), Hkt (10 minutes after pneumoperitoneum stopped) and Hro (before extubation)

• Changes in pre-, intra- and postoperative oxygenation index (OI)

  At a specific time point, the pulmonary oxygenation index (OI in mmHg) was calculated by the pre-defined formula: OI (mmHg) = PaO2 (mmHg)/FiO2 (%) where PaO2 was partial pressure of oxygen in arterial blood obtained by blood gas analysis and FiO2 was fraction of inspired oxygen. Changes in OI were recorded before induction, 1 hour after pneumoperitoneum, and day 1 after operation.

  before induction, 1 hour after pneumoperitoneum, and day 1 after operation

• Changes in pre-, intra- and postoperative alveolar-arterial oxygen gradient (A-aO2)

  At a specific time point, the alveolar-arterial oxygen gradient (A-aO2 in mmHg) was calculated as A-aO2 (mmHg) = (PB-PH2O)×FiO2 -PaCO2/R - PaO2 where PB (atmospheric pressure) was 760 mmHg, PH2O (saturated vapor pressure at room temperature) was 47 mmHg, and the R (respiration quotient) was 0.8, PaCO2 in mmHg and PaO2 in mmHg. Changes in A-aO2 were recorded.before induction, 1 hour after pneumoperitoneum, and day 1 after operation.

  before induction, 1 hour after pneumoperitoneum, and day 1 after operation

Secondary Outcomes (3)

• Chest radiography on day 1 after surgery

  day 1 after surgery

• Modified Clinical Pulmonary Infection Score (mCPIS)

  day 1 after surgery

• Incidence of postoperative pulmonary complications (PPCs)

  day 1 after surgery

Study Arms (2)

Lung-protective mechanical ventilation

EXPERIMENTAL

Vt=7 ml/kg IBW; an intraoperative 10 cmH2O in PEEP, recruitment maneuvers applying a stepwise increase in PEEP.

Procedure: Lung-protective mechanical ventilation

Conventional mechanical ventilation

NO INTERVENTION

the tidal volume was set at 10 ml/kg IBW without PEEP and (recruitment maneuvers) RM

Interventions

Lung-protective mechanical ventilation PROCEDURE

Patients were provided with a tidal volume of 7 ml/kg IBW and an intraoperative 10 cmH2O in PEEP. Simultaneously, the alveoli were recruited applying a stepwise increase in PEEP (from 4 to 10 cmH2O for 3 breaths, 10 to 15 cmH2O for 3 breaths, and 15 to 20 cmH2O for 10 breaths) with maximum PIP = 50 cmH2O \[24\]. The recruitment maneuvers were performed right after intubation, 30 minutes after CO2 insufflation, then every hour, and finally before extubation.

Lung-protective mechanical ventilation

Eligibility Criteria

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

You may qualify if:

• Elective abdominal laparoscopic surgeries under general anesthesia with an expected duration of greater than 2 hours.
• Age more than 18 years.
• American Society of Anesthesiologists (ASA) physical status I-III.
• A body mass index (BMI) less than 30 kg/m2.

You may not qualify if:

• Individuals who refused to participate in the study.
• Patients with preexisting cardiac or pulmonary comorbidities (for instance heart failure, intractable shock, chronic obstructive pulmonary disease, asthma, pulmonary infection, bronchiectasis, pulmonary metastases ).
• Any preexisting abnormalities on chest X-ray or spirometry.
• Neuromuscular disease.
• Liver cirrhosis (Child B or C).
• Chronic renal failure with dialysis.
• A need for prolonged mechanical ventilation after surgery.

Sponsors & Collaborators

• Vietnam Military Medical University: lead
• Vietnam National Cancer Hospital: collaborator

Study Sites (1)

Department of Anesthesia and Pain Medicine, Vietnam National Cancer Hospital

Hanoi, Ha Dong District, 100000, Vietnam

Location

Related Publications (11)

• Pi X, Cui Y, Wang C, Guo L, Sun B, Shi J, Lin Z, Zhao N, Wang W, Fu S, Li E. Low tidal volume with PEEP and recruitment expedite the recovery of pulmonary function. Int J Clin Exp Pathol. 2015 Nov 1;8(11):14305-14. eCollection 2015.

  PMID: 26823746 RESULT

• Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013 Jun;118(6):1307-21. doi: 10.1097/ALN.0b013e31829102de.

  PMID: 23542800 RESULT

• Liu J, Meng Z, Lv R, Zhang Y, Wang G, Xie J. Effect of intraoperative lung-protective mechanical ventilation on pulmonary oxygenation function and postoperative pulmonary complications after laparoscopic radical gastrectomy. Braz J Med Biol Res. 2019;52(6):e8523. doi: 10.1590/1414-431x20198523. Epub 2019 Jun 3.

  PMID: 31166383 RESULT

• Sprung J, Whalen FX, Comfere T, Bosnjak ZJ, Bajzer Z, Gajic O, Sarr MG, Schroeder DR, Liedl LM, Offord CP, Warner DO. Alveolar recruitment and arterial desflurane concentration during bariatric surgery. Anesth Analg. 2009 Jan;108(1):120-7. doi: 10.1213/ane.0b013e31818db6c7.

  PMID: 19095839 RESULT

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 RESULT

• Futier E, Constantin JM, Petit A, Jung B, Kwiatkowski F, Duclos M, Jaber S, Bazin JE. Positive end-expiratory pressure improves end-expiratory lung volume but not oxygenation after induction of anaesthesia. Eur J Anaesthesiol. 2010 Jun;27(6):508-13. doi: 10.1097/EJA.0b013e3283398806.

  PMID: 20404729 RESULT

• Hazebroek EJ, Haitsma JJ, Lachmann B, Bonjer HJ. Mechanical ventilation with positive end-expiratory pressure preserves arterial oxygenation during prolonged pneumoperitoneum. Surg Endosc. 2002 Apr;16(4):685-9. doi: 10.1007/s00464-001-8174-y. Epub 2001 Dec 31.

  PMID: 11972215 RESULT

• Whalen FX, Gajic O, Thompson GB, Kendrick ML, Que FL, Williams BA, Joyner MJ, Hubmayr RD, Warner DO, Sprung J. The effects of the alveolar recruitment maneuver and positive end-expiratory pressure on arterial oxygenation during laparoscopic bariatric surgery. Anesth Analg. 2006 Jan;102(1):298-305. doi: 10.1213/01.ane.0000183655.57275.7a.

  PMID: 16368847 RESULT

• Haliloglu M, Bilgili B, Ozdemir M, Umuroglu T, Bakan N. Low Tidal Volume Positive End-Expiratory Pressure versus High Tidal Volume Zero-Positive End-Expiratory Pressure and Postoperative Pulmonary Functions in Robot-Assisted Laparoscopic Radical Prostatectomy. Med Princ Pract. 2017;26(6):573-578. doi: 10.1159/000484693. Epub 2017 Oct 31.

  PMID: 29131002 RESULT

• Pelosi P, Barassi A, Severgnini P, Gomiero B, Finazzi S, Merlini G, d'Eril GM, Chiaranda M, Niederman MS. Prognostic role of clinical and laboratory criteria to identify early ventilator-associated pneumonia in brain injury. Chest. 2008 Jul;134(1):101-8. doi: 10.1378/chest.07-2546. Epub 2008 Apr 10.

  PMID: 18403669 RESULT

• Nguyen TK, Nguyen VL, Nguyen TG, Mai DH, Nguyen NQ, Vu TA, Le AN, Nguyen QH, Nguyen CT, Nguyen DT. Lung-protective mechanical ventilation for patients undergoing abdominal laparoscopic surgeries: a randomized controlled trial. BMC Anesthesiol. 2021 Mar 30;21(1):95. doi: 10.1186/s12871-021-01318-5.

  PMID: 33784987 DERIVED

Study Officials

• Kien T Nguyen, PhD

  Critical Care Medicine and ClinicalToxicology, Military Hospital 103

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An anesthesiologist who did not involve in the study set the ventilator in accordance with the protocol in the envelopes. Another anesthetist who was in charge of the patient collected data during surgery. The surgeons taking part in the procedures and patients were not informed of the ventilator setting. Physicians in post-anesthesia care unit who were not responsible for intraoperative care carried out the postoperative evaluation. The analysis of the postoperative chest X-ray was completed by a radiologist who was not involved in the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center of Emergency, Critical Care Medicine and Clinical Toxicology, Military Hospital 103

Model Details: Participants were randomly assigned to receive either lung-protective ventilation (LPV group) or conventional ventilation (CV group) at a ratio of 1:1.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 14, 2020
• Study Start: January 15, 2020
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: no criteria

Locations

VN (1)