Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04711317
Other study ID # PRIOROB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2021
Est. completion date November 30, 2022

Study information

Verified date December 2022
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators and other groups have demonstrated that high-flow nasal oxygen used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. The investigators also have data from a recent study that indicates that high-flow nasal oxygen might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The studies investigating the concept of high-flow nasal oxygen has up to this date excluded pregnant women. Pregnant woman is a patient group with known difficulties to maintain adequate saturation levels during apnoea. Due to smaller functional residual capacity their oxygen stores after preoxygenation are smaller compared to patients with a normal body mass index. The pregnant woman also have a higher oxygen demand and metabolism due to the growing placenta and the fetus. Pregnant women are therefore a patient group where a method that could prolong time until desaturation would be even more valuable and potentially could save lives. Based on the above, the investigators now aim to conduct a clinical pilot study, where pregnant women undergoing caesarian section under general anesthesia are pre and perioxygenated with high-flow nasal oxygen. Data from that group will be compared with patients preoxygenated in a traditional manner with tight facemask. This study is done to evaluate an established technique on a patient category that in theory could gain a lot from it.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult, >18 years old 2. Caesarian section under general anesthesia. 3. Pregnant in week 30 or later 4. Capable of understanding the study information and signing the written consent. Exclusion Criteria: 1. BMI >45 2. Dependency on non-invasive ventilation to maintain oxygen saturation

Study Design


Intervention

Device:
Nasal high flow oxygen
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen

Locations

Country Name City State
Sweden Karlstads Centralsjukhus Karlstad
Sweden Danderyds Hospital Stockholm
Sweden Karolinska University Hospital, Solna Stockholm
Sweden Södersjukhuset Stockholm

Sponsors (5)

Lead Sponsor Collaborator
Karolinska University Hospital Danderyds Hospital, Stockholm, Sweden, Karlstad Central Hospital, Östra Hospital, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with peripheral arterial oxygen saturation below 93% from start of pre-oxygenation until one minute after tracheal intubation and comparison between intervention and control arterial peripheral oxygen saturation Up to 1 minute after intubation
Secondary Comparison of Endtidal concentration of oxygen after intubation between intervention and control The first breaths after intubation eg. within 20 seconds of intubation
Secondary Comparison of Endtidal carbondioxide concentration after intubation between intervention and control The first breaths after intubation eg. within 20 seconds of intubation
Secondary Comparison of Number of patients with regurgitation of gastric contents between intervention and control During intubation eg up to 0 seconds after intubation
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas