Mechanical Ventilation Complication Clinical Trial
Official title:
Lung-protective Mechanical Ventilation for Patients Undergoing Abdominal Laparoscopic Surgeries: A Randomized Controlled Trial
Verified date | September 2020 |
Source | Vietnam Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 62 |
Est. completion date | June 24, 2020 |
Est. primary completion date | June 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Vietnam | Department of Anesthesia and Pain Medicine, Vietnam National Cancer Hospital | Hanoi | Ha Dong District |
Lead Sponsor | Collaborator |
---|---|
Vietnam Military Medical University | Vietnam National Cancer Hospital |
Vietnam,
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: — View Citation
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 Prostatec — View Citation
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. Epub 2001 Dec 31. — View Citation
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 Anaesthesio — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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/an — View Citation
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 surg — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | Chest radiography on day 1 after surgery | Postoperative (day 1) chest radiography was obtained at the bedside and was analyzed by a radiologist who did not get involved in the study. Pathological chest X-ray was defined as the presence of at least one of the followings: an increase in thickness of the interstitium, atelectasis, pleural effusion, localized or diffused infiltrates. | day 1 after surgery | |
Secondary | Modified Clinical Pulmonary Infection Score (mCPIS) | Modified Clinical Pulmonary Infection Score (mCPIS) was calculated for each patient on the first day after surgery. The modified original version of the Clinical Pulmonary Infection Score was described by pelosi et al. (2008) measuring based on body temperature, blood leukocytes, tracheal secretions, the ratio of PaO2/FiO2 and chest radiograph | day 1 after surgery | |
Secondary | Incidence of postoperative pulmonary complications (PPCs) | Incidence of postoperative pulmonary complications (PPCs in percentage) was measured in each group. PPCs were defined by the European Perioperative Clinical Outcome (EPCO) definitions including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis. | day 1 after surgery |
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