NCT05627024

Brief Summary

This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

November 14, 2022

Last Update Submit

July 18, 2024

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

  • the occurrence of atelectasis

    The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening.

    On the operating room within 40 minutes after awakening

Secondary Outcomes (2)

  • oxygenation index

    On the operating room within 40 minutes after awakening

  • bilateral diaphragmatic muscles

    On the operating room within 40 minutes after awakening

Study Arms (2)

Experimental: 30% Oxygen

EXPERIMENTAL

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 mins. After successful anesthesia induction, Fio2 will be adjusted to 30%, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected twice for blood gas analysis, the first once is in the non-oxygen inhalation state before anesthesia induction and the second is 30min before the end of surgery. Patients in both groups will be extubated in the operating room and then sent to the PACU.

Drug: 30% Oxygen

Placebo Comparator: 60% Oxygen

PLACEBO COMPARATOR

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 mins. After successful anesthesia induction, Fio2 will be adjusted to 60%, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Arterial blood will be collected twice for blood gas analysis, the first once is in the non-oxygen inhalation state before anesthesia induction and the second is 30min before the end of surgery. Patients in both groups will be extubated in the operating room and then sent to the PACU.

Drug: 60% Oxygen

Interventions

30% OxygenDRUG

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 mins. After successful anesthesia induction, Fio2 will be adjusted to 30%, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected twice for blood gas analysis, the first once is in the non-oxygen inhalation state before anesthesia induction and the second is 30min before the end of surgery. Patients in both groups will be extubated in the operating room and then sent to the PACU.

Experimental: 30% Oxygen
60% OxygenDRUG

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 mins. After successful anesthesia induction, Fio2 will be adjusted to 60%, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Arterial blood will be collected twice for blood gas analysis, the first once is in the non-oxygen inhalation state before anesthesia induction and the second is 30min before the end of surgery. Patients in both groups will be extubated in the operating room and then sent to the PACU.

Placebo Comparator: 60% Oxygen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with American Society of Anesthesiologist (ASA) physical status I-II;
  • Older than 18 years; Patients with operation time more than 2 hours and plan to extubate in the operating room;
  • Preoperative blood gas partial pressure of oxygen was more than 80mmHg;
  • Patients scheduled for elective neurosurgery were operated in the supine position.

You may not qualify if:

  • A history of acute lung injury with acute respiratory distress syndrome within three months;
  • Heart failure (New York Heart Association class) greater than IV, severe liver and kidney dysfunction (Child B or C liver failure, glomerular filtration rate \<30ml/min);
  • BMI \> 30 kg/m2.
  • The operation time is more than 10 hours;
  • The amount of bleeding was more than 500ml; The total fluid volume exceeded 3000ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In addition to the anesthesiologist on the day of surgery, the patients and all participants, statistical analysts, ward staff, surgeons, and treatment-outcome assessors are blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 25, 2022

Study Start

January 11, 2023

Primary Completion

July 18, 2024

Study Completion

July 18, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Locations

CN(1)