Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608602
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
TIDAL VOLUME ADJUSTMENT ACCORDING to FORCED VITAL CAPACITY VERSUS PREDICTED BODY WEIGHT in THORACIC SURGERY PATIENTS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The PULMONARY EFFECTS of TIDAL VOLUME ADJUSTMENT ACCORDING to FORCED VITAL CAPACITY VERSUS PREDICTED BODY WEIGHT in THORACIC SURGERY PATIENTS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the intraoperative and postoperative pulmonary effects of tidal volume adjustment according to force vital capacity in thoracic surgery patients The main question it aims to answer is
Is there any positive effect of tidal volume adjustment according to force vital capacity on intraoperative and postoperative lung function in thoracic surgery patients
Participants already taking tidal volume adjustment according to force vital capacity or predicted body weight during toracic surgery As part of the medical care of thoracic surgery patients intraoperative hemodynamic variables lung dynamics and blood gas values and postoperative pulmonary complications will be monitored
Is there any positive effect of tidal volume adjustment according to force vital capacity on intraoperative and postoperative lung function in thoracic surgery patients
Participants already taking tidal volume adjustment according to force vital capacity or predicted body weight during toracic surgery As part of the medical care of thoracic surgery patients intraoperative hemodynamic variables lung dynamics and blood gas values and postoperative pulmonary complications will be monitored
Detailed Description:
Patients over 18 years of age and American Society of Anesthesiologists ASA physical status I-III who scheduled for elective thoracic surgery under general anesthesia will be included Exclusion criteria age gt 18 years old ASA I-III III pregnancy presence of large bullae andor pneumothorax previous lung resection surgery intensive care unit ICU admission in the preoperative period predictive postoperative ICU admission pneumonectomy surgery and missing data
In the operating room all patients will be monitored with electrocardiogram pulse oximeter non-invasive arterial blood pressure Anesthesia management intraoperative and postoperative fluid management postoperative analgesia regimens were will be standard procedures at the clinic for all patients
During two-lung ventilation TLV mechanical ventilation will be set for a tidal volume TV of 7 mlpredicted body weight PBW for Group I FVC8 ml for Group II Other settings will be similar between two groups respiratory rate of 10-14 breathsmin inspiratory time Ti of 33 without inspiratory pause
Demographic data functional status ARISCAT score hemodynamic values respiratory measurements peripheral oxygen saturation SpO2 Ppeak Pplato PEEP TV compliance FiO2 end-tidal carbon dioxide EtCO2 blood gas analysis PaO2 PaCO2 PaO2 FiO2 rate the difference of PaCO2-EtCO2 and oxygen saturation index FiO2xMAPx100SpO2 will be recorded after intubation on TLV T1 after lateral position on TLV T2 after 30 min onset OLV T3 the end of OLV on TLV T4 and before extubation on TLV T5
Duration of anesthesia duration of OLV urine output estimated blood loss fluid therapy ml crystalloid and colloid the need for blood product ml intraoperative complications and the need for inotrope or vasopressor agent will also recorded during surgery
The patients will be visited during postoperative five days day 1 postoperative first day and respiratory complications pneumonia pneumothorax additional oxygen therapy respiratory failure acute respiratory distress syndrome unplanned invasive or noninvasive mechanical ventilation prolonged air leak pleural effusion atelectasis cardiopulmonary edema will be evaluated and recorded daily
Length of hospital stay and in-hospital mortality will be also recorded Hospitalization or intensive care unit admission within 30 days after surgery and mortality at 28 days will be assessed by calling the patients and their relatives by phone
In the operating room all patients will be monitored with electrocardiogram pulse oximeter non-invasive arterial blood pressure Anesthesia management intraoperative and postoperative fluid management postoperative analgesia regimens were will be standard procedures at the clinic for all patients
During two-lung ventilation TLV mechanical ventilation will be set for a tidal volume TV of 7 mlpredicted body weight PBW for Group I FVC8 ml for Group II Other settings will be similar between two groups respiratory rate of 10-14 breathsmin inspiratory time Ti of 33 without inspiratory pause
Demographic data functional status ARISCAT score hemodynamic values respiratory measurements peripheral oxygen saturation SpO2 Ppeak Pplato PEEP TV compliance FiO2 end-tidal carbon dioxide EtCO2 blood gas analysis PaO2 PaCO2 PaO2 FiO2 rate the difference of PaCO2-EtCO2 and oxygen saturation index FiO2xMAPx100SpO2 will be recorded after intubation on TLV T1 after lateral position on TLV T2 after 30 min onset OLV T3 the end of OLV on TLV T4 and before extubation on TLV T5
Duration of anesthesia duration of OLV urine output estimated blood loss fluid therapy ml crystalloid and colloid the need for blood product ml intraoperative complications and the need for inotrope or vasopressor agent will also recorded during surgery
The patients will be visited during postoperative five days day 1 postoperative first day and respiratory complications pneumonia pneumothorax additional oxygen therapy respiratory failure acute respiratory distress syndrome unplanned invasive or noninvasive mechanical ventilation prolonged air leak pleural effusion atelectasis cardiopulmonary edema will be evaluated and recorded daily
Length of hospital stay and in-hospital mortality will be also recorded Hospitalization or intensive care unit admission within 30 days after surgery and mortality at 28 days will be assessed by calling the patients and their relatives by phone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None