Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Hospital Israelita Albert Einstein | OTHER |
| University Hospital Carl Gustav Carus | OTHER |
Not provided
Not provided
Not provided
Not provided
To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation, the 'PROtective Ventilation using High versus LOw PEEP trial' (PROVHILO), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE).
Lung-protective intraoperative ventilation (LPV) has the potential to improve the outcome of surgery patients through a reduction in postoperative pulmonary complications. Use of intraoperative ventilation strategies that use a low tidal volume could result in intraoperative hypercapnia. However, hypocapnia remains surprisingly common during intraoperative ventilation, possibly meaning that anesthesiologists continue to use high, if not too high respiratory rates or tidal volumes.
Previous studies suggested associations between intraoperative derangement of end-tidal carbon dioxide (etCO2) and postoperative outcomes. Indeed, two studies in highly selected patient groups showed associations of intraoperative hypocapnia with prolonged length of hospital stay, in patients undergoing pancreaticoduodenectomy, and in patients undergoing hysterectomy.
To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation; PROVHILO and PROBESE.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with hypocapnia | We will use the intraoperatively collected etCO2 levels to classify patients as either 'with hypocapnia' or 'without hypercapnia', using the cutoff of 35 mmHg. A patient is considered 'hypocapnic' if the etCO2 was < 35 mm Hg at any point during surgery, from start of the study till end of the study |
| |
| without hypocapnia | We will use the intraoperatively collected etCO2 levels to classify patients as either 'with hypocapnia' or 'without hypercapnia', using the cutoff of 35 mmHg. A patient is considered 'hypocapnic' if the etCO2 was < 35 mm Hg at any point during surgery, from start of the study till end of the study, and classified as 'without hypocapnia' otherwise. In case of a missing value immediately before extubation, we will use the values as reported in the last hour of surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoperative mechanical ventilation with hypocapnia (etCO2 < 35 mm Hg) | Behavioral | A patient is considered 'hypocapnic' if the etCO2 was < 35 mm Hg at any point during surgery, from start of the study till end of the study and classified as 'without hypocapnia' otherwise. In case of a missing value immediately before extubation, we will use the values as reported in the last hour of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative pulmonary complications | Composite of predefined and collected postoperative pulmonary complications. Postoperative pulmonary complications included mild, moderate, and severe respiratory failure; acute respiratory distress syndrome; bronchospasm; new pulmonary infiltrate; pulmonary infection; aspiration pneumonitis; pleural effusions; atelectasis; cardiopulmonary edema; and pneumothorax. | Until day seven or hospital discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative complications | Defined as intraoperative hypotension, arrhythmias; or need for rescue for desaturations; or need for vasoactive drugs. | Intraoperatively |
| Incidence of intensive care unit admission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients undergoing mechanical ventilation for general anesthesia for surgery.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sabrine NT Hemmes, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Study Chair |
| David MP van Meenen, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Frederique Paulus, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Study Chair |
| Marcus J Schultz, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | SĂŁo Paulo | Brazil | ||||
| University Hospital Carl Gustav Carus, Technische Universität Dresden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32007240 | Background | Deng QW, Tan WC, Zhao BC, Wen SH, Shen JT, Xu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: a network meta-analysis of randomised controlled trials. Br J Anaesth. 2020 Mar;124(3):324-335. doi: 10.1016/j.bja.2019.10.024. Epub 2020 Jan 30. | |
| 25978326 | Background | Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706. |
Not provided
Not provided
The harmonized dataset will be available after the publication of the main results and under request to the steering committee
After the publication of the main results
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2022 | Dec 1, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| D016857 | Hypocapnia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| Hospital ClĂnico Universitario de Valencia |
| OTHER |
Not provided
Not provided
Not provided
|
Incidence of intensive care unit admission during hospital stay
| Until hospital discharge, death or 100 days, whichever comes first |
| Incidence of extrapulmonary pulmonary complications | Until day seven or hospital discharge, whichever comes first |
| Incidence of 7-day mortality | Until day seven or hospital discharge, whichever comes first | Mortality during the first seven days of hospitalization |
| Incidence of in-hospital mortality | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 days |
| Incidence of major postoperative complications | Collapsed composite of complications developing within the first seven postoperative combining severe postoperative pulmonary complications, sepsis, septic shock and/or acute kidney injury | Until day seven or hospital discharge, whichever comes first |
| Dresden |
| Germany |
| IRCCS San Martino Policlinico Hospital | Genoa | Italy |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| 24894577 | 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. |
| 30430440 | Background | Akkermans A, van Waes JAR, Thompson A, Shanks A, Peelen LM, Aziz MF, Biggs DA, Paganelli WC, Wanderer JP, Helsten DL, Kheterpal S, van Klei WA, Saager L. An observational study of end-tidal carbon dioxide trends in general anesthesia. Can J Anaesth. 2019 Feb;66(2):149-160. doi: 10.1007/s12630-018-1249-1. Epub 2018 Nov 14. |
| 28183549 | Background | Dony P, Dramaix M, Boogaerts JG. Hypocapnia measured by end-tidal carbon dioxide tension during anesthesia is associated with increased 30-day mortality rate. J Clin Anesth. 2017 Feb;36:123-126. doi: 10.1016/j.jclinane.2016.10.028. Epub 2016 Dec 2. |
| 34357567 | Background | Dong L, Takeda C, Yamazaki H, Kamitani T, Kimachi M, Hamada M, Fukuhara S, Mizota T, Yamamoto Y. Intraoperative end-tidal carbon dioxide and postoperative mortality in major abdominal surgery: a historical cohort study. Can J Anaesth. 2021 Nov;68(11):1601-1610. doi: 10.1007/s12630-021-02086-z. Epub 2021 Aug 6. |
| 33591427 | Background | Park JH, Lee HM, Kang CM, Kim KS, Jang CH, Hwang HK, Lee JR. Correlation of Intraoperative End-Tidal Carbon Dioxide Concentration on Postoperative Hospital Stay in Patients Undergoing Pylorus-Preserving Pancreaticoduodenectomy. World J Surg. 2021 Jun;45(6):1860-1867. doi: 10.1007/s00268-021-05984-x. Epub 2021 Feb 16. |
| 20613537 | Background | Wax DB, Lin HM, Hossain S, Porter SB. Intraoperative carbon dioxide management and outcomes. Eur J Anaesthesiol. 2010 Sep;27(9):819-23. doi: 10.1097/EJA.0b013e32833cca07. |
| 31157366 | Background | Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505. |
| 26947624 | 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. |
| 25693014 | 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. |
| 27620287 | Background | Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. |
| 33336298 | Background | van Meenen DMP, Serpa Neto A, Paulus F, Merkies C, Schouten LR, Bos LD, Horn J, Juffermans NP, Cremer OL, van der Poll T, Schultz MJ; MARS Consortium. The predictive validity for mortality of the driving pressure and the mechanical power of ventilation. Intensive Care Med Exp. 2020 Dec 18;8(Suppl 1):60. doi: 10.1186/s40635-020-00346-8. |
| 40930872 | Derived | Nasa P, van Meenen DMP, Paulus F, Ferrando C, Bluth T, Gama de Abreu M, Ball L, Bossers SM, Schober P, Schultz MJ, Serpa Neto A, Hemmes SNT; REPEAT; PROVHILO; PROBESE; investigators of the PROVE network; ESAIC CTN. Association of intraoperative end-tidal CO2 levels with postoperative outcomes: a patient-level analysis of two randomised clinical trials. Br J Anaesth. 2025 Dec;135(6):1761-1769. doi: 10.1016/j.bja.2025.07.076. Epub 2025 Sep 10. |