Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery

Oxygenation Clinical Trial

Official title:

Effect of Intraoperative Low Tidal Volume vs Intermediate Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044402
• Other study ID #: GanSu Province Hospital
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 8, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Gansu Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-III class;
• Colorectal cancer patients;
• Elective laparoscopic colorectal surgery;
• expected duration of surgery greater than 2 hours.

Exclusion Criteria:

• serious complications associated with other systems;
• severe cardiac insufficiency;
• renal failure;
• body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;
• the use of low tidal volume and consequent hypercapnia can induce harm;
• refusal to participate in the study.

Related Conditions & MeSH terms

• Oxygenation
• Pneumoperitoneum
• Respiratory

Intervention

Other:
• group L (Vt 6 ml/kg)
low tidal volume ventilation (tidal volume was set to 6 ml/kg)
• group I (Vt 8 ml/kg)
intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
dong zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2	the outcome in mmHg	the lowest value at one hour after extubation, day-1 to day-3
Primary	hypoxemia	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	pneumonia	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	bronchospasm	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	atelectasis	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	pulmonary congestion	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	respiratory failure	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	pleural effusion	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	pneumothorax	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Primary	unplanned requirement for postoperative invasive or noninvasive ventilation	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
Secondary	Tidal volume	the outcome in milliliter	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	respiratory rate	the outcome in times/minute (frequency)	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	dead space fraction	the outcome in fraction	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	A-aDO2	the outcome in mmHg	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	intrapulmonary shunt	the outcome in fraction	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	peak airway pressure	the outcome in cmH2O	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	plateau airway pressure	the outcome in cmH2O	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	mean airway pressure	the outcome in cmH2O	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	dynamic compliance	the outcome in milliliter/cmH2O	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
Secondary	arterial blood pH	the outcome in number	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood PO2	the outcome in mmHg	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood PCO2	the outcome in mmHg	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Hb	the outcome in g/dl	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Hct	the outcome in fraction	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood SO2	the outcome in fraction	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood K	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Na	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Ca	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Cl	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Glu	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood Lac	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood tBil	the outcome in umol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood SBE	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	arterial blood ABE	the outcome in mmol/L	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	PaO2/FiO2	the outcome in mmHg	before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
Secondary	unplanned intensive care unit admission	the outcome in fraction	From date of finishing surgery until the date of patient discharge, assessed up to 7 days
Secondary	intensive care unit length of stay	the outcome in days	From date of finishing surgery until the date of patient discharge, assessed up to 7 days
Secondary	postoperative mortality	the outcome in fraction	From date of finishing surgery until the date of patient discharge, assessed up to 7 days
Secondary	hospital length of stay	the outcome in days	From date of patient admission until the date of discharge, assessed up to 10 days