HypoxemiaNCT06248320
Sigh Ventilation on Postoperative Hypoxemia in Cardiac Surgery
A study testing Sigh ventilation in people with Hypoxemia and Postoperative Complications, run by Zhongda Hospital at 1 site in China.
Trial summary
Postoperative pulmonary complications (PPCs) remain a frequent event after pump-on cardiac surgery and are mostly characterized by postoperative hypoxemia.These complications are significant contributors to prolonged intensive care unit admissions and an escalation in in-hospital mortality rates. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxemia, Postoperative Complications, Cardiac Disease
- What is being tested?
- Sigh ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2024to 11 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac surgery with general anesthesia
- Conventional cardiopulmonary bypass and aortic cross clamp
- Providing written informed consent by the patient himself/herself or the next of kin
Who cannot join
- Emergent surgery including aortic dissection, cardiac rupture and active endocarditis surgery
- Left ventricular assist device implantation
- Patients anticipated to require intraoperative support with Extracorporeal Membrane Oxygenation (ECMO) or Intra-Aortic Balloon Pump (IABP)
- Chronic pulmonary disease requiring long-term home oxygen therapy
- Receiving invasive mechanical ventilation within 7 days prior to surgery
- Preoperative shock
Show all 10Show fewer
- Obstructive Sleep Apnea Syndrome (OSAS) requiring intermittent non-invasive ventilatort support
- Preoperative left ventricular ejection fraction<40%
- Pulmonary arterial systolic pressure>50 mmHg
- Redo surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perioperative Sigh Ventilation on Postoperative Hypoxemia and Pulmonary Complications After On-pump Cardiac Surgery: A Randomized Controlled Trial
Postoperative pulmonary complications (PPCs) remain a frequent event after pump-on cardiac surgery and are mostly characterized by postoperative hypoxemia.These complications are significant contributors to prolonged intensive care unit admissions and an escalation in in-hospital mortality rates.
The dual impact of general anesthesia with invasive mechanical ventilation results in ventilator-induced lung injury, while cardiac surgery introduces additional pulmonary insults. These include systemic inflammatory responses initiated by cardiopulmonary bypass and ischemic lung damage consequent to aortic cross-clamping. Contributing factors such as blood transfusions and postoperative pain further exacerbate the incidence of PPCs by increasing the permeability of the alveolar-capillary barrier and disrupting mucociliary functions, often culminating in pulmonary atelectasis.
Read more
Protective ventilation strategies, inspired by acute respiratory distress syndrome (ARDS) management protocols, involve the utilization of low tidal volumes (6-8mL/kg predicted body weight). However, the uniform application of low tidal volumes, especially when combined with the multifactorial pulmonary insults inherent to cardiac surgery, can precipitate surfactant dysfunction and induce atelectasis.
The role of pulmonary surfactant in maintaining alveolar stability is critical, necessitating continuous synthesis to sustain low surface tension and prevent alveolar collapse. The most potent stimulus for surfactant secretion is identified as the mechanical stretch of type II pneumocytes, typically induced by larger tidal volumes.
This background sets the foundation for a research study aimed at assessing the safety and efficacy of incorporating sighs into perioperative protective ventilation. This approach is hypothesized to mitigate postoperative hypoxemia and reduce the incidence of PPCs in patients undergoing scheduled on-pump cardiac surgery.
Read the detailed description
The purpose of this single center, parallel group, randomized controlled study is to evaluate the effect of a perioperative sigh ventilation strategy on postoperative outcomes during the first 7 days following cardiac surgery. The study will include 192 adult patients undergoing scheduled on-pump cardiac surgery. The sigh ventilation approach will combine sigh ventilation and lung protective ventilation (6-8 ml/kg/pbw) from intubation to extubation. It will be compared to a conventional approach without sigh ventilation, with lung protective ventilation and positive end-expiratory pressure (PEEP) setting same as the intervention arm. The primary endpoint is the Spo2/Fio2 ratio during the initial post extubation hour. The secondary endpoints are postoperative pulmonary complications and hospital length of stay .
- Being tested
- Sigh ventilation
- Keywords
- Mechanical ventilation, Cardiac Surgery, Hypoxemia, Pulmonary Complications
- Medical subject headings
- Hypoxia, Postoperative Complications, Heart Diseases, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigh ventilationProcedure or surgery
Sigh breaths were delivered from intubation to extubation. Intervention primarily conducted in the following three stages: 1. From intubation to surgical opening of the chest cavity; 2. From the surgical closure of the chest cavity close and continue unit the operating room exiting; 3. From Intensive Care Unit (ICU) arrival to Spontaneous breathing trial (SBT) start.
| Study group | Role | What they receive |
|---|---|---|
| Sigh ventilation | Experimental | * Sigh breaths consisting of increasing positive end-expiratory pressure (PEEP) that produces a plateau pressure of 35 cmH2O (or 40 cmH2O in patients with BMIs > 35). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation, from intubation to extubation.
* No sigh ventilation during thoracotomy
* Lung protective ventilation from intubation to extubation, consisted of low tidal volume (6-8ml/kg/pbw) and positive end-expiratory pressure setting according to ARDS low PEEP-FiO2 table Receives: Procedure: Sigh ventilation |
| Conventional ventilation | No intervention | - Lung protective ventilation from intubation to extubation, consisted of low tidal volume (6-8ml/kg/pbw) and positive end-expiratory pressure setting according to ARDS low PEEP-FiO2 table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average pulse oximetry (SpO2/FiO2)
Calculated the SpO2/FiO2 ratio every 15min during the initial postextubation hour, then averaged the SpO2/FiO2 ratios weighted by measurement interval. The comparison between arms was made through T-test.
Measured: 1 hour after endotracheal extubation
Secondary outcomes (9)
Proportion of respiratory failure
Mild respiratory failure: SpO2 < 90% or PaO2 < 60 mmHg after breathing ambient air for 10 min (excluding hypoventilation) and corrected with an oxygen supply of 1-3 L/min with a nasal cannula; Moderate respiratory failure: SpO2 < 90% or PaO2 < 60 mmHg despite a 3 L/min oxygen supply with a nasal cannula (excluding hypoventilation) and corrected with an oxygen supply from 4 to 10 L/ min with a face mask; Severe respiratory failure: SpO2 < 90% or PaO2 < 60 mmHg despite a 10 L/min oxygen supply with a face mask (excluding hypoventilation) and corrected with an oxygen supply > 10 L/min with a high-flow face mask or with non-invasive ventilation or with high-flow nasal oxygen therapy or with invasive mechanical ventilation. Using the worst score in the first 7 days postextubation for main analysis.
Tested between arms through ordinal logistic regression.
Measured: first 7 days postextubation
Severity of postoperative pulmonary complications
Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication. Using the worst score in the first 7 days after surgery for main analysis.
Tested between arms through ordinal logistic regression.
Measured: first 7 days after surgery
Invasive mechanical ventilation (IMV) days
Durations of invasive mechanical ventilation.
Measured: first 7 days after surgery
Reintubation rate
Occurrence of endotracheal reintubation.
Measured: first 7 days after surgery
Proportion of receiving non-invasive ventilation (NIV) or High-flow nasal cannula (HFNC) support
Tested through the Fisher exact test or chi-square test.
Measured: first 7 days after surgery
No ventilatory-support days
Days alive and not receive IMV, HFNC and non-invasive ventilatory support.
Measured: first 7 days after surgery
In-hospital mortality
Deaths occurred during hospital stay
Measured: From the day of surgery up to Hospital discharge or death, maximum censoring at day 28 after surgery
Length of ICU stay
Days since surgery until ICU discharge
Measured: From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery
Length of hospital stay
Days since surgery until Hospital discharge
Measured: From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start25 Feb 2024
- Primary completion22 Jul 2024
- Study completion11 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengmei Guo, Zhongda Hospital
- Investigators
- Fengmei Guo, PhD, MD, Study chair, Nanjing Zhongda Hospital, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248320
- Sponsor's protocol ID
- SIGHVENT
- Status last verified
- Oct 2024
- First submitted
- 30 Jan 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Z, Cheng Q, Huang S, Sun J, Xu J, Xie J, Cao H, Guo F. Effect of perioperative sigh ventilation on postoperative hypoxemia and pulmonary complications after on-pump cardiac surgery (E-SIGHT): study protocol for a randomized controlled trial. Trials. 2024 Sep 4;25(1):585. doi: 10.1186/s13063-024-08416-y.
PubMed 39232795
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Sigh Ventilation on Postoperative Hypoxemia and Pulmonary Complications After On-pump Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06248320
- Acronym / sponsor ID
- SIGHVENT
- Keywords
- Mechanical ventilation, Cardiac Surgery, Hypoxemia, Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 11 Aug 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pulmonary complications (PPCs) remain a frequent event after pump-on cardiac surgery and are mostly characterized by postoperative hypoxemia.These complications are significant contributors to prolonged intensive care unit admissions and an escalation in in-hospital mortality rates.
The dual impact of general anesthesia with invasive mechanical ventilation results in ventilator-induced lung injury, while cardiac surgery introduces additional pulmonary insults. These include systemic inflammatory responses initiated by cardiopulmonary bypass and ischemic lung damage consequent to aortic cross-clamping. Contributing factors such as blood transfusions and postoperative pain further exacerbate the incidence of PPCs by increasing the permeability of the alveolar-capillary barrier and disrupting mucociliary functions, often culminating in pulmonary atelectasis.
Protective ventilation strategies, inspired by acute respiratory distress syndrome (ARDS) management protocols, involve the utilization of low tidal volumes (6-8mL/kg predicted body weight). However, the uniform application of low tidal volumes, especially when combined with the multifactorial pulmonary insults inherent to cardiac surgery, can precipitate surfactant dysfunction and induce atelectasis.
The role of pulmonary surfactant in maintaining alveolar stability is critical, necessitating continuous synthesis to sustain low surface tension and prevent alveolar collapse. The most potent stimulus for surfactant secretion is identified as the mechanical stretch of type II pneumocytes, typically induced by larger tidal volumes.
This background sets the foundation for a research study aimed at assessing the safety and efficacy of incorporating sighs into perioperative protective ventilation. This approach is hypothesized to mitigate postoperative hypoxemia and reduce the incidence of PPCs in patients undergoing scheduled on-pump cardiac surgery.
Detailed description
The purpose of this single center, parallel group, randomized controlled study is to evaluate the effect of a perioperative sigh ventilation strategy on postoperative outcomes during the first 7 days following cardiac surgery. The study will include 192 adult patients undergoing scheduled on-pump cardiac surgery. The sigh ventilation approach will combine sigh ventilation and lung protective ventilation (6-8 ml/kg/pbw) from intubation to extubation. It will be compared to a conventional approach without sigh ventilation, with lung protective ventilation and positive end-expiratory pressure (PEEP) setting same as the intervention arm. The primary endpoint is the Spo2/Fio2 ratio during the initial post extubation hour. The secondary endpoints are postoperative pulmonary complications and hospital length of stay .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigh ventilation | Experimental | Procedure: Sigh ventilation* Sigh breaths consisting of increasing positive end-expiratory pressure (PEEP) that produces a plateau pressure of 35 cmH2O (or 40 cmH2O in patients with BMIs > 35). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation, from intubation to extubation. * No sigh ventilation during thoracotomy * Lung protective ventilation from intubation to extubation, consisted of low tidal volume (6-8ml/kg/pbw) and positive end-expiratory pressure setting according to ARDS low PEEP-FiO2 table |
| Conventional ventilation | No intervention | –- Lung protective ventilation from intubation to extubation, consisted of low tidal volume (6-8ml/kg/pbw) and positive end-expiratory pressure setting according to ARDS low PEEP-FiO2 table |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective cardiac surgery with general anesthesia
- Conventional cardiopulmonary bypass and aortic cross clamp
- Providing written informed consent by the patient himself/herself or the next of kin
Key exclusion criteria (10 listed)
- Emergent surgery including aortic dissection, cardiac rupture and active endocarditis surgery
- Left ventricular assist device implantation
- Patients anticipated to require intraoperative support with Extracorporeal Membrane Oxygenation (ECMO) or Intra-Aortic Balloon Pump (IABP)
- Chronic pulmonary disease requiring long-term home oxygen therapy
- Receiving invasive mechanical ventilation within 7 days prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigh ventilationSigh breaths were delivered from intubation to extubation. Intervention primarily conducted in the following three stages: 1. From intubation to surgical opening of the chest cavity; 2. From the surgical closure of the chest cavity close and continue unit the operating room exiting; 3. From Intensive Care Unit (ICU) arrival to Spontaneous breathing trial (SBT) start. | Procedure or surgery | Sigh ventilation |
Primary outcome
Time-weighted average pulse oximetry (SpO2/FiO2)
Time frame: 1 hour after endotracheal extubation
Calculated the SpO2/FiO2 ratio every 15min during the initial postextubation hour, then averaged the SpO2/FiO2 ratios weighted by measurement interval. The comparison between arms was made through T-test.
9 secondary outcomes
Proportion of respiratory failure
Time frame: first 7 days postextubation
Severity of postoperative pulmonary complications
Time frame: first 7 days after surgery
Invasive mechanical ventilation (IMV) days
Time frame: first 7 days after surgery
Reintubation rate
Time frame: first 7 days after surgery
Proportion of receiving non-invasive ventilation (NIV) or High-flow nasal cannula (HFNC) support
Time frame: first 7 days after surgery
No ventilatory-support days
Time frame: first 7 days after surgery
In-hospital mortality
Time frame: From the day of surgery up to Hospital discharge or death, maximum censoring at day 28 after surgery
Length of ICU stay
Time frame: From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery
Length of hospital stay
Time frame: From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Derived from this study: PubMed 39232795Wang Z, Cheng Q, Huang S, Sun J, Xu J, Xie J, Cao H, Guo F. Effect of perioperative sigh ventilation on postoperative hypoxemia and pulmonary complications after on-pump cardiac surgery (E-SIGHT): study protocol for a randomized controlled trial. Trials. 2024 Sep 4;25(1):585. doi: 10.1186/s13063-024-08416-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengmei Guo, PhD, MD study chair
Nanjing Zhongda Hospital, Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigh ventilation in people with Hypoxemia and Postoperative Complications, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average pulse oximetry (SpO2/FiO2) (time frame: 1 hour after endotracheal extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06248320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.