Detecting Post-Operative Respiratory Depression in Children

NCT01843933 | Completed Results

• 1 other identifier: 1112009471
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Due to the lingering effects of general anesthesia and the administration of medications for pain after surgery, children in the recovery room are at risk for breathing problems. While there are less data specific to children, in general 25% of patients in the recovery room experience complications from anesthesia. The most common complications involve the patient's airway and their ability to breath adequately. Currently, checks of oxygenation with a pulse oximetry monitor and of respiration through nursing assessments are used to detect breathing problems. However, these are believed not to be adequate for reliably recognizing significant respiratory depression until other dangerous events develop such as the cessation of breathing, severe drops in oxygen levels, or cardiac arrest. Capnography is a monitoring device that measures the amount of carbon dioxide being exhaled and assesses the adequacy of respiration. A small plastic cannula sits at the base of the nose and on the lip to continuously monitor the patient's breathing. Most children tolerate this device well and staff consider it easy to use. While capnography is routinely used in the operating room to monitor breathing, it is not used during post-operative care when patients are still at risk of breathing problems. Objectives: To determine if capnography can detect problems with breathing faster and more often than traditional monitors. To determine if the addition of capnography to routine monitoring will decrease the numbers of additional adverse events that occur in children undergoing post-operative care by allowing nurses to intervene in care faster and more frequently. Methods: In the first phase of this study, the investigators will apply the capnography monitor to children in the recover room and determine how often they experience breathing difficulties measured by this device. In the second phase, the investigators will educate staff on the use of capnography and what values are considered abnormal. Children will again have the capnography cannula placed on them as they enter the recovery room. They will then be divided into two groups - in one group the nurses in the recovery room will have access to the capnography monitor for their patients, whereas in the other group the nurses will not be able to see the readout from the monitor. The investigators will determine if children have fewer breathing problems and less additional adverse events when nurses use capnography in addition to the routine monitors already in place in the recovery room as compared to when nurses use standard monitoring alone. Potential Impact: If capnography can detect breathing problems prior to being identified by current monitoring devices, staff may be able to intervene more quickly and before more serious events occur in the children receiving post-operative care. This can reduce adverse events, improve patient safety, and avert harm in children. The adoption of this device for routine monitoring of post-operative care has the potential to save lives.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions

  Mild Events/Interventions: * Mild oxygen desaturation: Pulse oximetry \< 93% on room air or \<95% on oxygen * Hypopneic hypoventilation: ETCO2 values \< 30mmHg for \>30 seconds * Bradypneic hypoventilation: ETCO2 values \> 50mmHg for \>30 seconds * Stimulation: Verbally or physical stimulation to encourage breathing Moderate Events/Interventions: * Moderate oxygen desaturation: Pulse oximetry \< 85% on room air or \<90% on oxygen * Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for \>20 seconds * Airway obstruction: ETCO2 value of 0mmHg without cessation of respiratory effort * Airway repositioning: Jaw thrust or chin lift or use of a shoulder roll * Airway adjunct: Oral or nasal airway device Severe Events/Interventions: * Severe oxygen desaturation: Pulse oximetry \< 80% on room air or \<85% on oxygen * Assisted ventilation: Use of a bag-valve mask, a laryngeal mask airway or endotracheal intubation * Reversal medications: Use of naloxone or flumazenil

  Post operative period (From entering the PACU until discharge. Average time is 1 hour)

Study Arms (2)

Standard monitoring and blinded to capnography

NO INTERVENTION

Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.

Capnography

ACTIVE COMPARATOR

Capnography will be added to standard monitoring practices. A portable capnography monitor (Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion) will be used to collect and record data.

Device: Capnography

Interventions

Capnography DEVICE

Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion

Capnography

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients (1-20yo) undergoing a scheduled, elective procedure at Yale-New Haven Hospital.
• An English-speaking parent or guardian must be present in the pre-operative care area in order to provide informed consent.

You may not qualify if:

• Currently or expected to receive post-operative assisted ventilation via an endotracheal tube (ex. major cardiac surgery) or tracheostomy
• Being directly admitted to the Pediatric Intensive Care Unit or pediatric ward instead of the PACU
• Undergoing urgent or emergent surgical procedures (i.e. non-elective) or surgery that will preclude the use of a nasal-oral cannula (ex. facial reconstruction)
• Any disease or state that may lead to abnormal ETCO2 values or baseline abnormalities in pulse oximetry. These would include evidence of active asthma exacerbation such as wheeze, diabetic ketoacidosis, moderate to severe dehydration, cardiac abnormalities, severe lung disease, and major trauma as the reason for surgery.
• Inability to tolerate the nasal-oral cannula, if it is removed during the study period by the patient or family, or if subjects cry continuously during the study, which inhibits accurate readings on the monitor.

Sponsors & Collaborators

• Yale University: lead
• Thrasher Research Fund: collaborator

Study Sites (2)

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

Location

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06511, United States

Location

Related Publications (7)

• Ireland D. Unique concerns of the pediatric surgical patient: pre-, intra-, and postoperatively. Nurs Clin North Am. 2006 Jun;41(2):265-98, vii. doi: 10.1016/j.cnur.2006.01.007.

  PMID: 16698342 BACKGROUND

• Fu ES, Downs JB, Schweiger JW, Miguel RV, Smith RA. Supplemental oxygen impairs detection of hypoventilation by pulse oximetry. Chest. 2004 Nov;126(5):1552-8. doi: 10.1378/chest.126.5.1552.

  PMID: 15539726 BACKGROUND

• Tarrac SE. A description of intraoperative and postanesthesia complication rates. J Perianesth Nurs. 2006 Apr;21(2):88-96. doi: 10.1016/j.jopan.2006.01.006.

  PMID: 16600829 BACKGROUND

• Kluger MT, Bullock MF. Recovery room incidents: a review of 419 reports from the Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 2002 Nov;57(11):1060-6. doi: 10.1046/j.1365-2044.2002.02865.x.

  PMID: 12392453 BACKGROUND

• Hines R, Barash PG, Watrous G, O'Connor T. Complications occurring in the postanesthesia care unit: a survey. Anesth Analg. 1992 Apr;74(4):503-9. doi: 10.1213/00000539-199204000-00006.

  PMID: 1554116 BACKGROUND

• Lightdale JR, Mahoney LB, Fredette ME, Valim C, Wong S, DiNardo JA. Nurse reports of adverse events during sedation procedures at a pediatric hospital. J Perianesth Nurs. 2009 Oct;24(5):300-6. doi: 10.1016/j.jopan.2009.07.004.

  PMID: 19853814 BACKGROUND

• Lightdale JR, Goldmann DA, Feldman HA, Newburg AR, DiNardo JA, Fox VL. Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial. Pediatrics. 2006 Jun;117(6):e1170-8. doi: 10.1542/peds.2005-1709. Epub 2006 May 15.

  PMID: 16702250 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Capnography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Melissa Langhan
• Organization: Yale University

melissa.langhan@yale.edu

2037377413

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: May 1, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Locations

US (2)